| Verzenio (abemaciclib) [package insert]. FDA. |
Verzenio is a kinase inhibitor indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. |
12 |
| Verzenio (abemaciclib) [package insert]. FDA. |
Verzenio is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. |
6 |
| Verzenio (abemaciclib) [package insert]. FDA. |
Verzenio is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. |
3 |
| Verzenio (abemaciclib) [package insert]. FDA. |
Verzenio is a kinase inhibitor indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. |
3 |
| Akeega (abiraterone acetate and niraparib) [package insert]. FDA. |
AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA. |
4 |
| Krazati (adagrasib) [package insert]. FDA. |
KRAZATI is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s). |
1 |
| Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA. |
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease; or developed disease recurrence during or within six months of completing adjuvant therapy. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA. |
2 |
| Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA. |
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA. |
|
| Gilotrif (afatinib) [package insert]. FDA. |
GILOTRIF is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test (1.1) Limitations of Use: Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations. |
1 |
| Alecensa (alectinib) [package insert]. FDA. |
ALECENSA is a kinase inhibitor indicated for the adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors >= 4 cm or node positive) as detected by an FDA-approved test. |
2 |
| Alecensa (alectinib) [package insert]. FDA. |
ALECENSA is a kinase inhibitor indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. |
|
| Piqray (alpelisib) [package insert]. FDA. |
PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. |
3 |
| Rybrevant (amivantamab-vmjw) [package insert]. FDA. |
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. |
1 |
| Rybrevant (amivantamab-vmjw) [package insert]. FDA. |
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. |
1 |
| Trisenox (arsenic trioxide) [package insert]. FDA. |
TRISENOX is an arsenical indicated in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. |
2 |
| Trisenox (arsenic trioxide) [package insert]. FDA. |
TRISENOX is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. |
|
| Scemblix (asciminib) [package insert]. FDA. |
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with previously treated philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). |
2 |
| Scemblix (asciminib) [package insert]. FDA. |
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with Ph+ CML in CP with the T315I mutation. |
1 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on >= 1% of tumor cells, as determined by an FDA-approved test. |
1 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained >= 50% of tumor cells [TC >= 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering >= 10% of the tumor area [IC >= 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. |
2 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. |
1 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. |
1 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. |
2 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. |
2 |
| Ayvakit (avapritinib) [package insert]. FDA. |
AYVAKIT is a kinase inhibitor indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. |
1 |
| Mektovi (binimetinib) [package insert]. FDA. |
MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. |
2 |
| Mektovi (binimetinib) [package insert]. FDA. |
MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. |
1 |
| Blincyto (blinatumomab) [package insert]. FDA. |
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. |
2 |
| Blincyto (blinatumomab) [package insert]. FDA. |
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). |
|
| Blincyto (blinatumomab) [package insert]. FDA. |
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. |
1 |
| Bosulif (bosutinib) [package insert]. FDA. |
BOSULIF is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. |
3 |
| Bosulif (bosutinib) [package insert]. FDA. |
BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. |
|
| Adcetris (brentuximab vedotin) [package insert]. FDA. |
ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone. |
1 |
| Adcetris (brentuximab vedotin) [package insert]. FDA. |
ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. |
1 |
| Alunbrig (brigatinib) [package insert]. FDA. |
ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. |
1 |
| Xeloda (capecitabine) [package insert]. FDA. |
XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. |
1 |
| Truqap (capivasertib) [package insert]. FDA. |
TRUQAP is a kinase inhibitor indicated, in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. |
21 |
| Tabrecta (capmatinib) [package insert]. FDA. |
TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. |
2 |
| Libtayo (cemiplimab) [package insert]. FDA. |
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated in combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic. |
1 |
| Libtayo (cemiplimab) [package insert]. FDA. |
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated as single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) >= 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic. |
1 |
| Zykadia (ceritinib) [package insert]. FDA. |
ZYKADIA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. |
1 |
| Erbitux (cetuximab) [package insert]. FDA. |
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment. |
1 |
| Erbitux (cetuximab) [package insert]. FDA. |
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. |
1 |
| Erbitux (cetuximab) [package insert]. FDA. |
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. |
1 |
| Erbitux (cetuximab) [package insert]. FDA. |
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. |
1 |
| Cotellic (cobimetinib) [package insert]. FDA. |
COTELLIC is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. |
2 |
| Xalkori (crizotinib) [package insert]. FDA. |
XALKORI is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. |
2 |
| Xalkori (crizotinib) [package insert]. FDA. |
XALKORI is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. |
1 |
| Xalkori (crizotinib) [package insert]. FDA. |
XALKORI is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. |
2 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. |
2 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. |
1 |
| Vizimpro (dacomitinib) [package insert]. FDA. |
VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. |
2 |
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. |
6 |
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. |
|
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. |
2 |
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. |
|
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. |
|
| Jemperli (dostarlimab) [package insert]. FDA. |
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microstallite instability-high (MSI-H). |
2 |
| Jemperli (dostarlimab) [package insert]. FDA. |
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. |
1 |
| Jemperli (dostarlimab) [package insert]. FDA. |
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Imfinzi (durvalumab) [package insert]. FDA. |
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic aberrations. |
5 |
| Imfinzi (durvalumab) [package insert]. FDA. |
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). |
1 |
| Orserdu (elacestrant) [package insert]. FDA. |
ORSERDU is an estrogen receptor antagonist indicated for treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. |
1 |
| Idhifa (enasidenib) [package insert]. FDA. |
IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. |
9 |
| Braftovi (encorafenib) [package insert]. FDA. |
BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
2 |
| Braftovi (encorafenib) [package insert]. FDA. |
BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
1 |
| Braftovi (encorafenib) [package insert]. FDA. |
BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
1 |
| Rozlytrek (entrectinib) [package insert]. FDA. |
ROZLYTREK is a kinase inhibitor indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. |
1 |
| Rozlytrek (entrectinib) [package insert]. FDA. |
ROZLYTREK is a kinase inhibitor indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, (ii) are metastatic or where surgical resection is likely to result in severe morbidity, and (iii) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. |
3 |
| Balversa (erdafitinib) [package insert]. FDA. |
BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. |
5 |
| Tarceva (erlotinib) [package insert]. FDA. |
TARCEVA is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Safety and efficacy of TARCEVA have not been established in patients with NSCLC whose tumors have other EGFR mutations. TARCEVA is not recommended for use in combination with platinum-based chemotherapy. |
2 |
| Afinitor (everolimus) [package insert]. FDA. |
AFINITOR is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. |
3 |
| Faslodex (fulvestrant) [package insert]. FDA. |
FASLODEX is an estrogen receptor antagonist indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. |
3 |
| Faslodex (fulvestrant) [package insert]. FDA. |
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. |
3 |
| Faslodex (fulvestrant) [package insert]. FDA. |
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. |
3 |
| Faslodex (fulvestrant) [package insert]. FDA. |
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. |
6 |
| Lytgobi (futibatinib) [package insert]. FDA. |
LYTGOBI is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Iressa (gefitinib) [package insert]. FDA. |
IRESSA is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Limitation of Use: Safety and efficacy of IRESSA have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. |
2 |
| Mylotarg (gemtuzumab ozogamicin) [package insert]. FDA. |
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older. |
2 |
| Mylotarg (gemtuzumab ozogamicin) [package insert]. FDA. |
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older. |
|
| Xospata (gilteritinib) [package insert]. FDA. |
XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. |
8 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. |
4 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. |
|
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). |
2 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. |
|
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. |
2 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. |
1 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRa fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown. |
1 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). |
1 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. |
1 |
| Truseltiq (infigratinib) [package insert]. FDA. |
TRUSELTIQ is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
1 |
| Besponsa (inotuzumab ozogamicin) [package insert]. FDA. |
BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. |
1 |
| Yervoy (ipilimumab) [package insert]. FDA. |
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in combination with nivolumab. |
2 |
| Yervoy (ipilimumab) [package insert]. FDA. |
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>=1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab. |
1 |
| Yervoy (ipilimumab) [package insert]. FDA. |
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy. |
3 |
| Tibsovo (ivosidenib) [package insert]. FDA. |
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. |
15 |
| Tibsovo (ivosidenib) [package insert]. FDA. |
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with relapsed or refractory AML. |
|
| Tibsovo (ivosidenib) [package insert]. FDA. |
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes. |
5 |
| Tibsovo (ivosidenib) [package insert]. FDA. |
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated. |
5 |
| Tykerb (lapatinib) [package insert]. FDA. |
TYKERB is a kinase inhibitor indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. |
1 |
| Tykerb (lapatinib) [package insert]. FDA. |
TYKERB is a kinase inhibitor indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. |
3 |
| Vitrakvi (larotrectinib) [package insert]. FDA. |
VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. |
3 |
| Revlimid (lenalidomide) [package insert]. FDA. |
REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. |
1 |
| Lorbrena (lorlatinib) [package insert]. FDA. |
LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. |
1 |
| Margenza (margetuximab-cmkb) [package insert]. FDA. |
MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2- positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. |
4 |
| Rydapt (midostaurin) [package insert]. FDA. |
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation- positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. |
10 |
| Exkivity (mobocertinib) [package insert]. FDA. |
EXKIVITY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
1 |
| Nerlynx (neratinib) [package insert]. FDA. |
NERLYNX is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab based therapy. |
1 |
| Nerlynx (neratinib) [package insert]. FDA. |
NERLYNX is a kinase inhibitor indicated in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. |
1 |
| Tasigna (nilotinib) [package insert]. FDA. |
Tasigna is a kinase inhibitor indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. |
4 |
| Tasigna (nilotinib) [package insert]. FDA. |
Tasigna is a kinase inhibitor indicated for the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. |
|
| Tasigna (nilotinib) [package insert]. FDA. |
Tasigna is a kinase inhibitor indicated for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. |
|
| Zejula (niraparib) [package insert]. FDA. |
ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA. |
6 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adult patients with resectable (tumors >=4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery. |
3 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
24 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
15 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
|
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
4 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
|
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
2 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
28 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
8 |
| Rezlidhia (olutasidenib) [package insert]. FDA. |
REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. |
5 |
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated for adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. |
6 |
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. |
|
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. |
4 |
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. |
1 |
| Ibrance (palbociclib) [package insert]. FDA. |
IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. |
3 |
| Ibrance (palbociclib) [package insert]. FDA. |
IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant in patients with disease progression following endocrine therapy. |
3 |
| Vectibix (panitumumab) [package insert]. FDA. |
Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) in combination with FOLFOX for first-line treatment. Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown. |
1 |
| Vectibix (panitumumab) [package insert]. FDA. |
Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) >=1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS >=1%) as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an FDA-approved test. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS >=10) as determined by an FDA-approved test. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test. |
8 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [>=10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS >=10) as determined by an FDA approved test. |
2 |
| Pemazyre (pemigatinib) [package insert]. FDA. |
PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
2 |
| Pemazyre (pemigatinib) [package insert]. FDA. |
PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. |
1 |
| Perjeta (pertuzumab) [package insert]. FDA. |
PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. |
1 |
| Perjeta (pertuzumab) [package insert]. FDA. |
PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. |
2 |
| Perjeta (pertuzumab) [package insert]. FDA. |
PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. |
9 |
| Phesgo (pertuzumab and trastuzumab) [package insert]. FDA. |
PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. |
2 |
| Phesgo (pertuzumab and trastuzumab) [package insert]. FDA. |
PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. |
9 |
| Phesgo (pertuzumab and trastuzumab) [package insert]. FDA. |
PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with docetaxel for treatment of patients with HER2 positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. |
1 |
| Iclusig (ponatinib) [package insert]. FDA. |
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed Ph+ ALL, in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). |
1 |
| Iclusig (ponatinib) [package insert]. FDA. |
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with as monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. |
1 |
| Iclusig (ponatinib) [package insert]. FDA. |
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase). Limitations of Use: ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. |
1 |
| Gavreto (pralsetinib) [package insert]. FDA. |
GAVRETO is a kinase inhibitor indicated for treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). |
1 |
| Gavreto (pralsetinib) [package insert]. FDA. |
GAVRETO is a kinase inhibitor indicated for treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
1 |
| Cyramza (ramucirumab) [package insert]. FDA. |
CYRAMZA is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated in combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. |
2 |
| Augtyro (repotrectinib) [package insert]. FDA. |
AUGTYRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). |
1 |
| Augtyro (repotrectinib) [package insert]. FDA. |
AUGTYRO is a kinase inhibitor indicated for the treatment of adult and pedatric patients 12 years of age and older with solid tumors that (i) have a neutrophic tyrosine receptor kinase (NTRK) gene fusion and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbility, and (iii) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. |
3 |
| Kisqali (ribociclib) [package insert]. FDA. |
KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. |
6 |
| Kisqali (ribociclib) [package insert]. FDA. |
KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. |
3 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with relapsed or refractory, low grade or follicular, CD20-positive B- cell NHL as a single agent. |
2 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL) in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. |
3 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL) non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. |
|
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL) previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. |
2 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. |
3 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL). |
1 |
| Rubraca (rucaparib) [package insert]. FDA. |
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. |
12 |
| Rubraca (rucaparib) [package insert]. FDA. |
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. |
4 |
| Trodelvy (sacituzumab govitecan) [package insert]. FDA. |
TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. |
1 |
| Trodelvy (sacituzumab govitecan) [package insert]. FDA. |
TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. |
3 |
| Retevmo (selpercatinib) [package insert]. FDA. |
RETEVMO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. |
1 |
| Retevmo (selpercatinib) [package insert]. FDA. |
RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. |
1 |
| Retevmo (selpercatinib) [package insert]. FDA. |
RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). |
1 |
| Retevmo (selpercatinib) [package insert]. FDA. |
RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
1 |
| Lumakras (sotorasib) [package insert]. FDA. |
LUMAKRAS is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Talzenna (talazoparib) [package insert]. FDA. |
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. |
2 |
| Talzenna (talazoparib) [package insert]. FDA. |
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). |
24 |
| Tazverik (tazemetostat) [package insert]. FDA. |
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
7 |
| Tepmetko (tepotinib) [package insert]. FDA. |
TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. |
2 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naive patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. |
2 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. |
2 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. |
|
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. |
1 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. |
1 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use: MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. |
1 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. |
1 |
| Herceptin (trastuzumab) [package insert]. FDA. |
Herceptin is a HER2/neu receptor antagonist indicated for the treatment of HER2 -overexpressing breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin. |
1 |
| Herceptin (trastuzumab) [package insert]. FDA. |
Herceptin is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either (i) in the metastatic setting, or (ii) in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. |
1 |
| Imjudo (tremelimumab-actl) [package insert]. FDA. |
IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. |
5 |
| Tukysa (tucatinib) [package insert]. FDA. |
TUKYSA is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. |
1 |
| Tukysa (tucatinib) [package insert]. FDA. |
TUKYSA is a kinase inhibitor indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. |
|
| Zelboraf (vemurafenib) [package insert]. FDA. |
ZELBORAF is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. |
1 |
| Zelboraf (vemurafenib) [package insert]. FDA. |
ZELBORAF is indicated for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation. |
2 |
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. |
|
| Rybrevant (amivantamab-vmjw) [package insert]. FDA. |
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. |
2 |
| Lazcluze (lazertinib) [package insert]. FDA. |
LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. |
2 |
| Rybrevant (amivantamab-vmjw) [package insert]. FDA. |
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. |
2 |
| Elahere (mirvetuximab soravtansine-gynx) [package insert]. FDA. |
ELAHERE is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FR-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. |
3 |
| Ojemda (tovorafenib) [package insert]. FDA. |
OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. |
4 |
| Imfinzi (durvalumab) [package insert]. FDA. |
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. |
4 |
| Krazati (adagrasib) [package insert]. FDA. |
KRAZATI is an inhibitor of the RAS GTPase family indicated in combination with cetuximab for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials. |
1 |
| Voranigo (vorasidenib) [package insert]. FDA. |
VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection. |
20 |
| Kisqali (ribociclib) [package insert]. FDA. |
KISQALI is a kinase inhibitor indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. |
6 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>= 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. |
1 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy. |
3 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. |
2 |
| Itovebi (inavolisib) [package insert]. FDA. |
ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. |
3 |
| Vyloy (zolbetuximab) [package insert]. FDA. |
VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test. |
2 |
| Ziihera (zanidatamab-hrii) [package insert]. FDA. |
ZIHERA is a bispecific HER2-directed antibody indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
3 |
| Bizengri (zenocutuzumab-zbco) [package insert]. FDA. |
BIZENGRI is a bispecific HER2- and HER3-directed antibody indicated for the treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Bizengri (zenocutuzumab-zbco) [package insert]. FDA. |
BIZENGRI is a bispecific HER2- and HER3-directed antibody indicated for the treatment of adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Ensacove (ensartinib) [package insert]. FDA. |
ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. |
1 |
| Braftovi (encorafenib) [package insert]. FDA. |
BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
1 |
| Scemblix (asciminib) [package insert]. FDA. |
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). |
1 |
| Revuforj (revumenib) [package insert]. FDA. |
REVUFORJ is a menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older. |
4 |
| Afinitor (everolimus) [package insert]. FDA. |
AFINITOR is a kinase inhibitor indicated for the treatment of adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. |
2 |
| Afinitor (everolimus) [package insert]. FDA. |
AFINITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. |
2 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab. |
2 |
| Adcetris (brentuximab vedotin) [product information]. EMA. |
ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD). |
1 |
| Adcetris (brentuximab vedotin) [product information]. EMA. |
ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT). |
1 |
| Adcetris (brentuximab vedotin) [product information]. EMA. |
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): (i) following ASCT, or (ii) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. |
1 |
| Adcetris (brentuximab vedotin) [product information]. EMA. |
ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy. |
1 |
| Afinitor (everolimus) [product information]. EMA. |
Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. |
3 |
| Akeega (abiraterone acetate and niraparib) [product information]. EMA. |
Akeega is indicated with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. |
4 |
| Alecensa (alectinib) [product information]. EMA. |
Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
1 |
| Alecensa (alectinib) [product information]. EMA. |
Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. |
1 |
| Alecensa (alectinib) [product information]. EMA. |
Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive non-small cell lung cancer (NSCLC) at high risk of recurrence. |
1 |
| Alunbrig (brigatinib) [product information]. EMA. |
Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. |
1 |
| Alunbrig (brigatinib) [product information]. EMA. |
Alunbrig is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. |
1 |
| Avastin (bevacizumab) [product information]. EMA. |
Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. |
2 |
| Ayvakyt (avapritinib) [product information]. EMA. |
AYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. |
1 |
| Besponsa (inotuzumab ozogamicin) [product information]. EMA. |
BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). |
2 |
| Blincyto (blinatumomab) [product information]. EMA. |
BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. |
2 |
| Blincyto (blinatumomab) [product information]. EMA. |
BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. |
1 |
| Blincyto (blinatumomab) [product information]. EMA. |
BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. |
1 |
| Blincyto (blinatumomab) [product information]. EMA. |
BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy. |
1 |
| Bosulif (bosutinib) [product information]. EMA. |
Bosulif is indicated for the treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML). |
1 |
| Bosulif (bosutinib) [product information]. EMA. |
Bosulif is indicated for the treatment of adult patients with CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. |
1 |
| Braftovi (encorafenib) [product information]. EMA. |
Encorafenib is indicated in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
2 |
| Braftovi (encorafenib) [product information]. EMA. |
Encorafenib is indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy. |
1 |
| Braftovi (encorafenib) [product information]. EMA. |
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. |
1 |
| Caprelsa (vandetanib) [product information]. EMA. |
Caprelsa is indicated for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older. |
1 |
| Cotellic (cobimetinib) [product information]. EMA. |
Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
2 |
| Cyramza (ramucirumab) [product information]. EMA. |
Cyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations. |
1 |
| Taxotere (docetaxel) [product information]. EMA. |
TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. |
2 |
| Enhertu (trastuzumab deruxtecan) [product information]. EMA. |
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. |
2 |
| Enhertu (trastuzumab deruxtecan) [product information]. EMA. |
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. |
1 |
| Enhertu (trastuzumab deruxtecan) [product information]. EMA. |
Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. |
2 |
| Enhertu (trastuzumab deruxtecan) [product information]. EMA. |
Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. |
2 |
| Erbitux (cetuximab) [product information]. EMA. |
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. |
1 |
| Erbitux (cetuximab) [product information]. EMA. |
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in combination with irinotecan-based chemotherapy. |
1 |
| Erbitux (cetuximab) [product information]. EMA. |
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in first-line in combination with FOLFOX. |
1 |
| Faslodex (fulvestrant) [product information]. EMA. |
Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. |
1 |
| Faslodex (fulvestrant) [product information]. EMA. |
Faslodex is indicated in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. |
3 |
| Gavreto (pralsetinib) [product information]. EMA. |
Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. |
1 |
| Iressa (gefitinib) [product information]. EMA. |
IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK. |
1 |
| Giotrif (afatinib) [product information]. EMA. |
GIOTRIF as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). |
1 |
| Herceptin (trastuzumab) [product information]. EMA. |
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. |
2 |
| Herceptin (trastuzumab) [product information]. EMA. |
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. |
2 |
| Herceptin (trastuzumab) [product information]. EMA. |
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. |
2 |
| Herceptin (trastuzumab) [product information]. EMA. |
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. |
2 |
| Herceptin (trastuzumab) [product information]. EMA. |
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). |
2 |
| Herceptin (trastuzumab) [product information]. EMA. |
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. |
4 |
| Herceptin (trastuzumab) [product information]. EMA. |
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. |
2 |
| Herceptin (trastuzumab) [product information]. EMA. |
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. |
2 |
| Herceptin (trastuzumab) [product information]. EMA. |
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. |
4 |
| Ibrance (palbociclib) [product information]. EMA. |
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. |
3 |
| Ibrance (palbociclib) [product information]. EMA. |
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy. |
3 |
| Glivec (imatinib) [product information]. EMA. |
Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. |
1 |
| Glivec (imatinib) [product information]. EMA. |
Glivec is indicated for the treatment of adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. |
1 |
| Glivec (imatinib) [product information]. EMA. |
Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. |
1 |
| Glivec (imatinib) [product information]. EMA. |
Glivec is indicated for the treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. |
1 |
| Glivec (imatinib) [product information]. EMA. |
Glivec is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. |
4 |
| Glivec (imatinib) [product information]. EMA. |
Glivec is indicated for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR_ rearrangement. |
1 |
| Glivec (imatinib) [product information]. EMA. |
Glivec is indicated for the treatment of the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). |
1 |
| Glivec (imatinib) [product information]. EMA. |
Glivec is indicated for the treatment of the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. |
1 |
| Iclusig (ponatinib) [product information]. EMA. |
Iclusig is indicated in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. |
1 |
| Iclusig (ponatinib) [product information]. EMA. |
Iclusig is indicated in adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. |
2 |
| Imfinzi (durvalumab) [product information]. EMA. |
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on >= 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy. |
1 |
| Imfinzi (durvalumab) [product information]. EMA. |
IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations. |
1 |
| Imfinzi (durvalumab) [product information]. EMA. |
IMFINZI in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) or IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). |
2 |
| Imjudo (tremelimumab) [product information]. EMA. |
IMJUDO in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations. |
1 |
| Jemperli (dostarlimab) [product information]. EMA. |
JEMPERLI is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. |
2 |
| Jemperli (dostarlimab) [product information]. EMA. |
JEMPERLI is indicated as monotherapy for the treatment of adult patients with dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with a platinum-containing regimen. |
2 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a >= 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. |
2 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations. |
5 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a >= 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. |
1 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) >= 10. |
1 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS >= 1. |
3 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a >= 50% TPS and progressing on or after platinum -containing chemotherapy. |
1 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA as monotherapy is indicated for adults with MSI-H or dMMR colorectal cancer in the following settings: first-line treatment of metastatic colorectal cancer; treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine -based combination therapy. |
2 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation. |
2 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. |
6 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA, in combination with platinum and fluoropyrimidine -based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS >= 10. |
2 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence. |
1 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS >= 10 and who have not received prior chemotherapy for metastatic disease. |
3 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS >= 1. |
2 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro -oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS >= 1. |
2 |
| Keytruda (pembrolizumab) [product information]. EMA. |
KEYTRUDA, in combination with fluoropyrimidine and platinum -containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro -oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS >= 1. |
2 |
| Kadcyla (trastuzumab emtansine) [product information]. EMA. |
Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. |
2 |
| Kadcyla (trastuzumab emtansine) [product information]. EMA. |
Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. |
2 |
| Kisqali (ribociclib) [product information]. EMA. |
Kisqali is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. |
6 |
| Krazati (adagrasib) [product information]. EMA. |
KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy. |
1 |
| Libtayo (cemiplimab) [product information]. EMA. |
LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in >= 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. |
1 |
| Libtayo (cemiplimab) [product information]. EMA. |
LIBTAYO in combination with platinum_based chemotherapy is indicated for the first_line treatment of adult patients with NSCLC expressing PD-L1 (in >= 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. |
1 |
| Lorviqua (lorlatinib) [product information]. EMA. |
Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. |
1 |
| Lorviqua (lorlatinib) [product information]. EMA. |
Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI. |
1 |
| Lumykras (sotorasib) [product information]. EMA. |
LUMYKRAS as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. |
1 |
| Lynparza (olaparib) [product information]. EMA. |
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. |
12 |
| Lynparza (olaparib) [product information]. EMA. |
Lynparza in combination with bevacizumab is indicated for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability. |
15 |
| Lynparza (olaparib) [product information]. EMA. |
Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. |
2 |
| Lynparza (olaparib) [product information]. EMA. |
Lynparza is indicated as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. |
2 |
| Lynparza (olaparib) [product information]. EMA. |
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. |
2 |
| Lynparza (olaparib) [product information]. EMA. |
Lynparza is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. |
4 |
| Lynparza (olaparib) [product information]. EMA. |
Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel. |
1 |
| Lytgobi (futibatinib) [product information]. EMA. |
Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. |
2 |
| MabThera (rituximab) [product information]. EMA. |
MabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine,prednisolone) chemotherapy. |
2 |
| MabThera (rituximab) [product information]. EMA. |
MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged >= 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL). |
3 |
| Mekinist (trametinib) [product information]. EMA. |
Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
4 |
| Mekinist (trametinib) [product information]. EMA. |
Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. |
2 |
| Mekinist (trametinib) [product information]. EMA. |
Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation. |
2 |
| Mektovi (binimetinib) [product information]. EMA. |
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
2 |
| Mektovi (binimetinib) [product information]. EMA. |
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. |
1 |
| Mylotarg (gemtuzumab ozogamicin) [product information]. EMA. |
MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL). |
1 |
| Nerlynx (neratinib) [product information]. EMA. |
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago. |
6 |
| Opdivo (nivolumab) [product information]. EMA. |
OPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. |
3 |
| Opdivo (nivolumab) [product information]. EMA. |
OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1%. |
3 |
| Opdivo (nivolumab) [product information]. EMA. |
OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC. |
1 |
| Opdivo (nivolumab) [product information]. EMA. |
OPDIVO in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy. |
2 |
| Opdivo (nivolumab) [product information]. EMA. |
OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression >= 1%. |
1 |
| Opdivo (nivolumab) [product information]. EMA. |
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression >= 1% |
1 |
| Opdivo (nivolumab) [product information]. EMA. |
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) >= 5. |
6 |
| Opdualag (relatlimab / nivolumab) [product information]. EMA. |
Opdualag is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%. |
1 |
| Orserdu (elacestrant) [product information]. EMA. |
ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor. |
1 |
| Pemazyre (pemigatinib) [product information]. EMA. |
Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. |
2 |
| Perjeta (pertuzumab) [product information]. EMA. |
Perjeta is indicated for use in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. |
2 |
| Perjeta (pertuzumab) [product information]. EMA. |
Perjeta is indicated for use in combination with trastuzumab and chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. |
5 |
| Perjeta (pertuzumab) [product information]. EMA. |
Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. |
1 |
| Phesgo (pertuzumab / trastuzumab) [product information]. EMA. |
Phesgo is indicated for use in combination with chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. |
2 |
| Phesgo (pertuzumab / trastuzumab) [product information]. EMA. |
Phesgo is indicated for use in combination with chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. |
7 |
| Phesgo (pertuzumab / trastuzumab) [product information]. EMA. |
Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. |
1 |
| Piqray (alpelisib) [product information]. EMA. |
Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy. |
3 |
| Retsevmo (selpercatinib) [product information]. EMA. |
Retsevmo as monotherapy is indicated for the treatment of adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. |
1 |
| Retsevmo (selpercatinib) [product information]. EMA. |
Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate). |
1 |
| Retsevmo (selpercatinib) [product information]. EMA. |
Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC). |
1 |
| Retsevmo (selpercatinib) [product information]. EMA. |
Retsevmo as monotherapy is indicated for the treatment of adults with advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted. |
1 |
| Revlimid (lenalidomide) [product information]. EMA. |
Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. |
1 |
| Rozlytrek (entrectinib) [product information]. EMA. |
Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. |
1 |
| Rozlytrek (entrectinib) [product information]. EMA. |
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than one month with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion (i) who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and (ii) who have not received a prior NTRK inhibitor, (iii) who have no satisfactory treatment options. |
3 |
| Rydapt (midostaurin) [product information]. EMA. |
Rydapt is indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive. |
1 |
| Scemblix (asciminib) [product information]. EMA. |
Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors. |
1 |
| Spexotras (trametinib) [product information]. EMA. |
Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. |
1 |
| Spexotras (trametinib) [product information]. EMA. |
Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment. |
1 |
| Sprycel (dasatinib [anhydrous]) [product information]. EMA. |
SPRYCEL is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. |
1 |
| Sprycel (dasatinib [anhydrous]) [product information]. EMA. |
SPRYCEL is indicated for the treatment of adult patients with Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. |
2 |
| Sprycel (dasatinib [anhydrous]) [product information]. EMA. |
SPRYCEL is indicated for the treatment of paediatric patients with newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. |
1 |
| Sprycel (dasatinib [anhydrous]) [product information]. EMA. |
SPRYCEL is indicated for the treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy. |
1 |
| Tabrecta (capmatinib) [product information]. EMA. |
Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. |
2 |
| Tafinlar (dabrafenib) [product information]. EMA. |
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
4 |
| Tafinlar (dabrafenib) [product information]. EMA. |
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. |
2 |
| Tafinlar (dabrafenib) [product information]. EMA. |
Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation. |
2 |
| Tagrisso (osimertinib) [product information]. EMA. |
TAGRISSO as monotherapy is indicated for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. |
2 |
| Tagrisso (osimertinib) [product information]. EMA. |
TAGRISSO as monotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. |
1 |
| Tagrisso (osimertinib) [product information]. EMA. |
TAGRISSO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. |
1 |
| Tagrisso (osimertinib) [product information]. EMA. |
TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. |
4 |
| Talzenna (talazoparib) [product information]. EMA. |
Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. |
2 |
| Tarceva (erlotinib) [product information]. EMA. |
Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations. |
1 |
| Tarceva (erlotinib) [product information]. EMA. |
Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy |
1 |
| Tasigna (nilotinib) [product information]. EMA. |
Tasigna is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase. |
1 |
| Tasigna (nilotinib) [product information]. EMA. |
Tasigna is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available. |
1 |
| Tasigna (nilotinib) [product information]. EMA. |
Tasigna is indicated for the treatment of paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. |
1 |
| Tecentriq (atezolizumab) [product information]. EMA. |
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC (i) after prior platinum-containing chemotherapy, or (ii) who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression >= 5%. |
1 |
| Tecentriq (atezolizumab) [product information]. EMA. |
Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on >= 50% of tumour cells (TC) and who do not have EGFR mutant or ALK-positive NSCLC. |
1 |
| Tecentriq (atezolizumab) [product information]. EMA. |
Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. |
2 |
| Tecentriq (atezolizumab) [product information]. EMA. |
Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK-positive NSCLC. |
3 |
| Tecentriq (atezolizumab) [product information]. EMA. |
Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression >= 50% TC or >= 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC. |
2 |
| Tecentriq (atezolizumab) [product information]. EMA. |
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq. |
2 |
| Tecentriq (atezolizumab) [product information]. EMA. |
Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression >= 1% and who have not received prior chemotherapy for metastatic disease. |
1 |
| Tepmetko (tepotinib) [product information]. EMA. |
TEPMETKO as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. |
2 |
| Tibsovo (ivosidenib) [product information]. EMA. |
Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy. |
5 |
| Tibsovo (ivosidenib) [product information]. EMA. |
Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. |
5 |
| Tremelimumab AstraZeneca (tremelimumab) [product information]. EMA. |
Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations. |
5 |
| Trisenox (arsenic trioxide) [product information]. EMA. |
RISENOX is indicated for induction of remission, and consolidation in adult patients with either newly diagnosed low-to-intermediate risk acute promyelocytic leukemia (APL) (white blood cell count, <= 10 x 10^3 / ul) in combination with all-trans-retinoic acid (ATRA) or relapsed / refractory acute promyelocytic leukemia (APL) (previous treatment should have included a retinoid and chemotherapy). Both contexts should be characterized by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukemia / retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. |
1 |
| Trodelvy (sacituzumab govitecan) [product information]. EMA. |
Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease. |
1 |
| Trodelvy (sacituzumab govitecan) [product information]. EMA. |
Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. |
3 |
| Tukysa (tucatinib) [product information]. EMA. |
TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens. |
1 |
| Tyverb (lapatinib) [product information]. EMA. |
Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting. |
2 |
| Tyverb (lapatinib) [product information]. EMA. |
Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy. |
2 |
| Tyverb (lapatinib) [product information]. EMA. |
Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population. |
2 |
| Vectibix (panitumumab) [product information]. EMA. |
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) in first-line in combination with FOLFOX or FOLFIRI. |
2 |
| Vectibix (panitumumab) [product information]. EMA. |
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). |
1 |
| Vectibix (panitumumab) [product information]. EMA. |
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. |
1 |
| KG. EMA. |
Venclyxto monotherapy is indicated for the treatment of CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor. |
3 |
| KG. EMA. |
Venclyxto monotherapy is indicated for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed chemoimmunotherapy and a B-cell receptor pathway inhibitor. |
2 |
| Verzenios (abemaciclib) [product information]. EMA. |
Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. |
3 |
| Verzenios (abemaciclib) [product information]. EMA. |
Verzenios is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. |
9 |
| Vitrakvi (larotrectinib) [product information]. EMA. |
VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options. |
3 |
| Vizimpro (dacomitinib) [product information]. EMA. |
Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. |
1 |
| Xalkori (crizotinib) [product information]. EMA. |
XALKORI as monotherapy is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
1 |
| Xalkori (crizotinib) [product information]. EMA. |
XALKORI as monotherapy is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
1 |
| Xalkori (crizotinib) [product information]. EMA. |
XALKORI as monotherapy is indicated for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). |
1 |
| Xalkori (crizotinib) [product information]. EMA. |
XALKORI as monotherapy is indicated for the treatment of paediatric patients (age >= 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL). |
1 |
| Xalkori (crizotinib) [product information]. EMA. |
XALKORI as monotherapy is indicated for the treatment of paediatric patients (age >= 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumour (IMT). |
1 |
| Xospata (gilteritinib) [product information]. EMA. |
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. |
2 |
| Yervoy (ipilimumab) [product information]. EMA. |
YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. |
3 |
| Yervoy (ipilimumab) [product information]. EMA. |
YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy. |
2 |
| Yervoy (ipilimumab) [product information]. EMA. |
YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression >= 1%. |
1 |
| Zelboraf (vemurafenib) [product information]. EMA. |
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation- positive unresectable or metastatic melanoma. |
2 |
| Zydelig (idelalisib) [product information]. EMA. |
Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. |
3 |
| Zykadia (ceritinib) [product information]. EMA. |
Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
1 |
| Zykadia (ceritinib) [product information]. EMA. |
Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. |
1 |
| Tevimbra (tislelizumab) [product information]. EMA. |
Tevimbra in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on >= 50% of tumor cells with no EGFR or ALK positive mutations and who have (i) locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or (ii) metastatic NSCLC. |
2 |
| Rybrevant (amivantamab) [product information]. EMA. |
Rybrevant is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations. |
1 |
| Rybrevant (amivantamab) [product information]. EMA. |
Rybrevant is indicated as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based chemotherapy. |
1 |
| Truqap (capivasertib) [product information]. EMA. |
TRUQAP is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. In pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of LHRH agonist according to current clinical practices should be considered. |
8 |
| Balversa (erdafitinib) [product information]. EMA. |
Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting. |
8 |
| Vyloy (zolbetuximab) [product information]. EMA. |
Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive. |
2 |
| Afatinib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of Epidermal Growth Factor Receptor (EGFR) TKI- naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). |
1 |
| Alectinib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. |
1 |
| Alectinib Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
1 |
| Asciminib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase (CP), who have previously been treated with two or more tyrosine kinase inhibitors (TKIs). |
1 |
| Bosutinib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotonib and dasatinib are not considered appropriate treatment options. |
1 |
| Brigatinib Therapy. NCCP National SACT Regimen. HSE. |
For the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. |
1 |
| Brigatinib Therapy. NCCP National SACT Regimen. HSE. |
Monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. |
1 |
| Ceritinib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. |
1 |
| Cobimetinib and Vemurafenib Therapy. NCCP National SACT Regimen. HSE. |
Cobimetinib and vemurafenib in combination are indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
2 |
| Crizotinib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
1 |
| Dabrafenib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
2 |
| Dacomitinib Monotherapy. NCCP National SACT Regimen. HSE. |
Monotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations |
1 |
| Encorafenib and Binimetinib Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with advanced (unresectable or metastatic) melanoma with a BRAF V600 mutation. |
2 |
| Entrectinib Therapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors |
1 |
| Lorlatinib Therapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), following disease progression on (i) alectinib or ceritinib as the first ALK-targeted treatment or (ii) crizotinib and at least one other ALK-targeted treatment. |
1 |
| Lorlatinib Therapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously not treated with an ALK inhibitor. |
1 |
| Midostaurin, DAUNOrubicin and Cytarabine Induction Therapy. NCCP National SACT Regimen. HSE. |
Midostaurin is indicated in combination with standard DAUNOrubicin and cytarabine induction chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive. |
1 |
| Neratinib Therapy. NCCP National SACT Regimen. HSE. |
Extended adjuvant treatment of adults with early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago. |
6 |
| Niraparib and Abiraterone acetate (Akeega) and prednisoLONE Therapy. NCCP National SACT Regimen. HSE. |
Niraparib in combination with abiraterone acetate (Akeega) and predniSONE/prednisoLONE for the treatment of adults with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. |
3 |
| Olaparib (Tablet) and Bevacizumab Therapy. NCCP National SACT Regimen. HSE. |
Olaparib in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability. |
14 |
| Olaparib (Tablet) Monotherapy. NCCP National SACT Regimen. HSE. |
Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA 1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube cancer, and primary peritoneal carcinoma who are in response (complete or partial) following completion of first-line platinum based chemotherapy |
12 |
| Olaparib (Tablet) Monotherapy. NCCP National SACT Regimen. HSE. |
Maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer who are in response (complete response or partial) to platinum-based chemotherapy |
12 |
| Olaparib (Tablet) Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. |
4 |
| Osimertinib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). |
1 |
| Osimertinib Monotherapy. NCCP National SACT Regimen. HSE. |
First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. |
1 |
| Osimertinib Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy for adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) whose tumour has epidermal growth factor receptor (EGFR) exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations. |
2 |
| PONATinib Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib, nilotinib and bosutinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. |
1 |
| PONATinib Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. |
2 |
| Talazoparib Therapy. NCCP National SACT Regimen. HSE. |
Talazoparib is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy or be considered unsuitable for endocrine-based therapy. |
2 |
| Trametinib and Dabrafenib Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
2 |
| Trametinib and Dabrafenib Therapy. NCCP National SACT Regimen. HSE. |
Adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. |
2 |
| Vemurafenib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. |
2 |
| Venetoclax Monotherapy 2021, version number 3, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/400.pdf. NCCP National SACT Regimen. HSE. |
Treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor. |
3 |
| Venetoclax Monotherapy 2021, version number 3, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/400.pdf. NCCP National SACT Regimen. HSE. |
Treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor |
1 |
| Zanubrutinib Therapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), who are treatment naive and have del(17p) and/or TP53-mutated disease. |
3 |
| Acalabrutinib (Tablets) Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of previously untreated CLL in the presence of 17p deletion or TP53 mutation in adult patients unsuitable for chemoimmunotherapy. |
3 |
| Ibrutinib Therapy CLL / Waldenstroms Macroglobulinaemia. NCCP National SACT Regimen. HSE. |
As a single agent for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. |
3 |
| Idelalisib and riTUXimab Therapy. NCCP National SACT Regimen. HSE. |
In combination with riTUXimab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. |
3 |
| Nivolumab 3mg/kg with Ipilimumab 1mg/kg Therapy. NCCP National SACT Regimen. HSE. |
Nivolumab in combination with ipilimumab for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer (MSI-H mCRC) after prior fluoropyrimidine-based combination chemotherapy. |
2 |
| Pembrolizumab 200mg Monotherapy. NCCP National SACT Regimen. HSE. |
First-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a >= 50% tumour proportion score (TPS) with no EGFR mutations or ALK translocations. |
2 |
| Pembrolizumab 200mg Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy whose tumours express PD-L1 with a combined positive score (CPS) >= 10. |
1 |
| Pembrolizumab 200mg Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS >= 1 |
1 |
| Pembrolizumab 200mg Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of recurrent, or metastatic cervical cancer with disease progression on or after chemotherapy in adults whose tumours express PD-L1 with a CPS >= 1 |
1 |
| Pembrolizumab 200mg Monotherapy. NCCP National SACT Regimen. HSE. |
First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults |
2 |
| Larotrectinib Monotherapy - Paediatric. NCCP National SACT Regimen. HSE. |
For the treatment of paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, (i) who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and (ii) who have no satisfactory treatment options |
3 |
| Larotrectinib Monotherapy - Adult. NCCP National SACT Regimen. HSE. |
For the treatment of adult patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, (i) who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and (ii) who have no satisfactory treatment options |
3 |
| Gefitinib Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK |
1 |
| Erlotinib Therapy. NCCP National SACT Regimen. HSE. |
First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations |
1 |
| Erlotinib Therapy. NCCP National SACT Regimen. HSE. |
Switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy |
1 |
| Trastuzumab Emtansine (Kadcyla) - 21 days. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: (i) Received prior therapy for locally advanced or metastatic disease, or (ii) Developed disease recurrence during or within six months of completing adjuvant therapy. |
1 |
| Palbociclib Therapy - 28 day. NCCP National SACT Regimen. HSE. |
Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor |
3 |
| Palbociclib Therapy - 28 day. NCCP National SACT Regimen. HSE. |
Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy |
3 |
| Ribociclib Therapy - 28 day. NCCP National SACT Regimen. HSE. |
Treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine-based therapy in combination with an aromatase inhibitor. |
3 |
| Ribociclib Therapy - 28 day. NCCP National SACT Regimen. HSE. |
Treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine based therapy or in women who have received prior endocrine therapy. In pre or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist. |
6 |
| Inotuzumab Ozogamicin Monotherapy. NCCP National SACT Regimen. HSE. |
Monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). |
2 |
| Blinatumomab Paediatric Therapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation |
1 |
| Brentuximab vedotin, Etoposide, methylPREDNISolone, Cytarabine and CISplatin, (ESHAP) therapy (BRESHAP). NCCP National SACT Regimen. HSE. |
Treatment of adult patients with relapsed/refractory CD30+ Hodgkin's lymphoma |
1 |
| Pertuzumab and Trastuzumab and Chemotherapy Therapy - 21 day cycle. NCCP National SACT Regimen. HSE. |
Pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. |
2 |
| Pertuzumab and Trastuzumab and Chemotherapy Therapy - 21 day cycle. NCCP National SACT Regimen. HSE. |
Pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of adult patients with HER2-positive breast cancer at high risk of recurrence. |
5 |
| Gemtuzumab ozogamicin DAUNOrubicin and cytarabine Therapy (AML induction). NCCP National SACT Regimen. HSE. |
Gemtuzumab ozogamicin is indicated for combination therapy with DAUNOrubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo CD33 positive Acute Myeloid Leukemia (AML), except acute promyelocytic leukaemia |
1 |
| Pembrolizumab, PEMEtrexed and CARBOplatin (AUC 5) Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab is indicated in combination with PEMEtrexed and CARBOplatin for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations |
1 |
| Pembrolizumab, PEMEtrexed and CISplatin Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab is indicated in combination with PEMEtrexed and CISplatin for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations |
1 |
| Durvalumab Monotherapy 10mg/kg - 14 Day. NCCP National SACT Regimen. HSE. |
As monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 >= 1% on tumour cells and whose disease has not progressed following platinum-based chemo-radiation therapy (CRT) |
1 |
| Atezolizumab Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. |
2 |
| Atezolizumab Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are considered cisplatin ineligible and whose tumours have a PD-L1 expression >= 5%. |
1 |
| Atezolizumab Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression >= 50% tumour cells (TC) or >= 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC. |
2 |
| Atezolizumab Monotherapy. NCCP National SACT Regimen. HSE. |
Adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumours have PD-L1 expression on >= 50% of tumour cells and who do not have EGFR mutant or ALK-positive mutations. |
1 |
| Trastuzumab Emtansine (Kadcyla) Early Breast Cancer Therapy - 21 days. NCCP National SACT Regimen. HSE. |
As a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy |
1 |
| Pembrolizumab, CARBOplatin (AUC 5) and 5-Fluorouracil Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab is indicated, in combination with CARBOplatin and 5-Fluorouracil, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS >= 1. |
1 |
| Pembrolizumab, Cisplatin and 5-Fluorouracil Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab is indicated, in combination with CISplatin and 5-fluorouracil, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS >= 1. |
1 |
| Nivolumab, ipilimumab, CARBOplatin and PACLitaxel Therapy. NCCP National SACT Regimen. HSE. |
First-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitising EGFR mutation or ALK translocation. |
1 |
| Nivolumab, ipilimumab, PEMEtrexed and CARBOplatin Therapy. NCCP National SACT Regimen. HSE. |
First-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitising EGFR mutation or ALK translocation. |
1 |
| Nivolumab, ipilimumab, PEMEtrexed and CISplatin Therapy. NCCP National SACT Regimen. HSE. |
First-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitising EGFR mutation or ALK translocation. |
1 |
| Atezolizumab and nab-PACLitaxel Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression >= 1% and who have not received prior chemotherapy for metastatic disease |
1 |
| Blinatumomab Therapy (ALL with MRD >= 0.1%). NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% |
1 |
| Blinatumomab for Relapsed Paediatric ALL: Consolidation Therapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukaemia (ALL) as part of the consolidation therapy. |
1 |
| Pertuzumab and Trastuzumab (Phesgo), PACLitaxel and CARBOplatin Therapy (TRAIN-2). NCCP National SACT Regimen. HSE. |
Neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. |
1 |
| Brentuximab vedotin Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy |
1 |
| Brentuximab vedotin Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with CD30+ Hodgkins Lymphoma (HL) at increased risk of relapse or progression following an autologous haematopoietic stem cell transplant (ASCT). |
1 |
| Brentuximab vedotin Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) |
1 |
| Brentuximab vedotin Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option |
1 |
| Brentuximab vedotin and ICE Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL) |
1 |
| Pembrolizumab 200mg, CISplatin 80mg/m2 and 5-Fluorouracil Infusional Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS >= 10. |
2 |
| Nivolumab 480mg, CISplatin 80mg/m2 and 5-Fluorouracil Infusional Therapy. NCCP National SACT Regimen. HSE. |
Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression >= 1%. |
1 |
| Atezolizumab 1680mg Monotherapy - 28 Day. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. |
2 |
| Atezolizumab 1680mg Monotherapy - 28 Day. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression >= 5% |
1 |
| Atezolizumab 1680mg Monotherapy - 28 Day. NCCP National SACT Regimen. HSE. |
As monotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression >= 50% tumour cells (TC) or >= 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC |
2 |
| Atezolizumab 1680mg Monotherapy - 28 Day. NCCP National SACT Regimen. HSE. |
Adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumours have PD-L1 expression on >= 50% of tumour cells and who do not have EGFR mutant or ALK-positive mutations. |
1 |
| Pembrolizumab and FOLFOX-6 Modified Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS >= 10. |
1 |
| Blinatumomab Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with relapsed or refractory B cell precursor (BCP) Philadelphia chromosome negative acute lymphoblastic leukaemia (ALL) who have received no prior salvage treatment for relapsed/refractory (R/R) disease and are considered eligible for transplant (i.e. as a bridge-to-transplant). |
1 |
| Pertuzumab/Trastuzumab (Phesgo) and Weekly PACLitaxel Therapy - 21 day cycle. NCCP National SACT Regimen. HSE. |
Pertuzumab/trastuzumab (Phesgo) is indicated in combination with PACLitaxel in adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease where patients are intolerant of, have had significant toxicity to or are deemed clinically unsuitable for DOCEtaxel |
1 |
| Pertuzumab,Trastuzumab and Weekly PACLitaxel Therapy - 21 day cycle. NCCP National SACT Regimen. HSE. |
Pertuzumab is indicated in combination with trastuzumab and PACLitaxel in adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease where patients are intolerant of, have had significant toxicity to or are deemed clinically unsuitable for DOCEtaxel |
1 |
| Pertuzumab/Trastuzumab (Phesgo) and DOCEtaxel Therapy - 21 day cycle. NCCP National SACT Regimen. HSE. |
Pertuzumab/ trastuzumab (Phesgo) is indicated in combination with DOCEtaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease. |
1 |
| Pertuzumab,Trastuzumab and DOCEtaxel Therapy - 21 day cycle. NCCP National SACT Regimen. HSE. |
Pertuzumab is indicated in combination with trastuzumab and DOCEtaxel in adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease. |
1 |
| Pertuzumab/Trastuzumab (Phesgo) and Vinorelbine. NCCP National SACT Regimen. HSE. |
Pertuzumab/trastuzumab (Phesgo) and vinorelbine for the treatment of adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease where patients are deemed clinically unsuitable for taxane based therapy. |
1 |
| Pertuzumab, Trastuzumab, and Vinorelbine. NCCP National SACT Regimen. HSE. |
Pertuzumab in combination with trastuzumab and vinorelbine for the treatment of adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease where patients are deemed clinically unsuitable for taxane based therapy |
1 |
| Pertuzumab/Trastuzumab (Phesgo) Maintenance Therapy. NCCP National SACT Regimen. HSE. |
Pertuzumab/ trastuzumab (Phesgo) for the maintenance treatment of adult patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, where this is a continuation of treatment for patients who have completed the chemotherapy component of the treatment. |
1 |
| DOCEtaxel, CARBOplatin, Trastuzumab and Pertuzumab (TCHP) Therapy. NCCP National SACT Regimen. HSE. |
Neoadjuvant treatment of adult patients with HER2-positive locally advanced, inflammatory or early breast cancer at high risk of recurrence. |
1 |
| Nivolumab 360mg and Chemotherapy. NCCP National SACT Regimen. HSE. |
Nivolumab in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1%. |
5 |
| Pembrolizumab 200mg, weekly CARBOplatin AUC 1.5 and PACLitaxel 80mg/m 2 followed by DOXOrubicin and cycloPHOSphamide (AC 60/600) Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. |
1 |
| Trastuzumab (IV) Monotherapy - 21 days. NCCP National SACT Regimen. HSE. |
HER2 positive metastatic breast cancer (MBC). |
1 |
| Trastuzumab (IV) Monotherapy - 21 days. NCCP National SACT Regimen. HSE. |
HER2 positive early breast cancer (EBC). |
1 |
| Trastuzumab (IV) Monotherapy - 7 days. NCCP National SACT Regimen. HSE. |
Treatment of patients with HER2 positive metastatic breast cancer (MBC). |
1 |
| Bevacizumab 10mg/kg - 14 days. NCCP National SACT Regimen. HSE. |
In combination with paclitaxel is indicated for first-line treatment of adult patients with HER2-negative metastatic breast cancer. |
1 |
| Bevacizumab 15mg/kg Therapy - 21 days. NCCP National SACT Regimen. HSE. |
In combination with PACLitaxel is indicated for first-line treatment of adult patients with HER2-negative metastatic breast cancer. |
1 |
| Bevacizumab 15mg/kg Therapy - 21 days. NCCP National SACT Regimen. HSE. |
In combination with erlotinib is indicated for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous cell lung cancer with Epidermal Growth Factor (EGFR) activating mutations |
1 |
| Capecitabine Monotherapy. NCCP National SACT Regimen. HSE. |
Adjuvant treatment of stage I to IIIB, triple negative breast cancer (TNBC) in patients with residual invasive disease after neoadjuvant chemotherapy treatment. |
1 |
| Lapatinib and Capecitabine Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with breast cancer, whose tumours overexpress HER2 in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which should have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting. |
1 |
| Tamoxifen Monotherapy. NCCP National SACT Regimen. HSE. |
Adjuvant treatment of oestrogen receptor positive breast cancer in pre- or post-menopausal women. |
1 |
| Tamoxifen Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of oestrogen receptor positive advanced breast cancer in pre- or post-menopausal women. |
1 |
| Anastrozole Monotherapy. NCCP National SACT Regimen. HSE. |
Treatment of hormone receptor positive locally advanced or metastatic breast cancer in post-menopausal women. |
3 |
| Anastrozole Monotherapy. NCCP National SACT Regimen. HSE. |
Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. |
3 |
| DOCEtaxel, CARBOplatin and Trastuzumab (TCH) - 21 days. NCCP National SACT Regimen. HSE. |
Adjuvant treatment HER2 positive early breast cancer |
1 |
| Trastuzumab Subcutaneous 21 days - Metastatic Breast Cancer. NCCP National SACT Regimen. HSE. |
HER2 positive metastatic breast cancer (MBC) as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. |
1 |
| Trastuzumab Subcutaneous 21 days - Metastatic Breast Cancer. NCCP National SACT Regimen. HSE. |
HER2 positive metastatic breast cancer (MBC) in combination with PACLitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. |
1 |
| Trastuzumab Subcutaneous 21 days - Metastatic Breast Cancer. NCCP National SACT Regimen. HSE. |
HER2 positive metastatic breast cancer (MBC) in combination with DOCEtaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. |
1 |
| Trastuzumab Subcutaneous 21 days - Metastatic Breast Cancer. NCCP National SACT Regimen. HSE. |
HER2 positive metastatic breast cancer (MBC) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. |
3 |
| Trastuzumab Subcutaneous 21 days - Early Breast Cancer. NCCP National SACT Regimen. HSE. |
HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). |
1 |
| Trastuzumab Subcutaneous 21 days - Early Breast Cancer. NCCP National SACT Regimen. HSE. |
HER2 positive early breast cancer (EBC) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with PACLitaxel or DOCEtaxel. |
2 |
| Trastuzumab Subcutaneous 21 days - Early Breast Cancer. NCCP National SACT Regimen. HSE. |
HER2 positive early breast cancer (EBC) in combination with adjuvant chemotherapy consisting of DOCEtaxel and CARBOplatin. |
1 |
| Trastuzumab Subcutaneous 21 days - Early Breast Cancer. NCCP National SACT Regimen. HSE. |
HER2 positive early breast cancer (EBC) in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab therapy, for locally advanced (including inflammatory) disease or tumours >2cm in diameter. |
1 |
| Everolimus and Exemestane Therapy. NCCP National SACT Regimen. HSE. |
Treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. |
3 |
| CARBOplatin (AUC 6) and Weekly PACLitaxel 80mg/m2 followed by Dose Dense DOXOrubicin cycloPHOSphamide Therapy-Triple Negative Breast Cancer Therapy. NCCP National SACT Regimen. HSE. |
Neoadjuvant treatment of triple negative breast carcinoma. |
1 |
| Fulvestrant Therapy. NCCP National SACT Regimen. HSE. |
Treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy. |
1 |
| Fulvestrant Therapy. NCCP National SACT Regimen. HSE. |
Treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease progression on or after adjuvant anti-oestrogen therapy. |
1 |
| Letrozole Monotherapy. NCCP National SACT Regimen. HSE. |
Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. |
3 |
| Letrozole Monotherapy. NCCP National SACT Regimen. HSE. |
Neo-adjuvant treatment of postmenopausal women with hormone receptor positive breast cancer. |
3 |
| Exemestane Monotherapy. NCCP National SACT Regimen. HSE. |
Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer |
3 |
| Gemcitabine and CARBOplatin (AUC2) Therapy - 21 days. NCCP National SACT Regimen. HSE. |
Treatment of locally recurrent metastatic triple negative breast cancer. |
1 |
| DOXOrubicin, cycloPHOSphamide (AC 60/600) 21 day followed by weekly PACLitaxel (80) and weekly Trastuzumab Therapy (AC-TH). NCCP National SACT Regimen. HSE. |
Adjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer. |
1 |
| DOXOrubicin, cycloPHOSphamide (AC 60/600) 21 day followed by weekly PACLitaxel (80) and weekly Trastuzumab Therapy (AC-TH). NCCP National SACT Regimen. HSE. |
Neoadjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer. |
1 |
| PACLitaxel (80) and Trastuzumab Therapy - 7 day (12 weeks). NCCP National SACT Regimen. HSE. |
Adjuvant Treatment of HER2 positive, Node-Negative Breast Cancer of tumour size <= 3cm. |
1 |
| Abemaciclib Therapy. NCCP National SACT Regimen. HSE. |
Abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. |
12 |
| Pertuzumab and Trastuzumab Therapy. NCCP National SACT Regimen. HSE. |
Pertuzumab in combination with trastuzumab for the maintenance treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, where this is a continuation of treatment for patients who have completed the chemotherapy component of the treatment. |
1 |
| DOCEtaxel, CARBOplatin, Trastuzumab (S/C) and Pertuzumab (TCH(S/C)P) Therapy. NCCP National SACT Regimen. HSE. |
Neoadjuvant treatment of adult patients with HER2-positive locally advanced, inflammatory or early breast cancer at high risk of recurrence. |
1 |
| CARBOplatin (AUC 2) weekly and PACLitaxel 80mg/m2 followed by Dose Dense DOXOrubicin cycloPHOSphamide Therapy - Triple Negative Breast Cancer Therapy. NCCP National SACT Regimen. HSE. |
Neoadjuvant treatment of triple negative breast carcinoma |
1 |
| Pertuzumab, Trastuzumab, PACLitaxel and CARBOplatin Therapy (TRAIN-2). NCCP National SACT Regimen. HSE. |
Neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. |
1 |
| DOCEtaxel, CARBOplatin and Pertuzumab/Trastuzumab (Phesgo)(TCHP) Therapy. NCCP National SACT Regimen. HSE. |
Neoadjuvant treatment of adult patients with HER2-positive locally advanced, inflammatory or early breast cancer at high risk of recurrence. |
1 |
| Pembrolizumab 200mg, CARBOplatin AUC 5 and weekly PACLitaxel 80mg/m 2 followed by DOXOrubicin and cycloPHOSphamide (AC 60/600) Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. |
1 |
| Dose Dense DOXOrubicin, cycloPHOSphamide (AC 60/600) 14 day followed by weekly PACLitaxel (80) and weekly Trastuzumab Therapy (DD AC-TH). NCCP National SACT Regimen. HSE. |
Adjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer. |
1 |
| Dose Dense DOXOrubicin, cycloPHOSphamide (AC 60/600) 14 day followed by weekly PACLitaxel (80) and weekly Trastuzumab Therapy (DD AC-TH). NCCP National SACT Regimen. HSE. |
Neoadjuvant Treatment of HER2 positive, High Risk Node Negative or Node Positive Breast Cancer. |
1 |
| Cetuximab Therapy-7 day. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing RAS wild-type metastatic colorectal cancer (mCRC) in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. |
1 |
| Panitumumab 6mg/kg Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) as monotherapy after failure of fluoropyrimidine, oxaliplatin, and irinotecan containing chemotherapy regimens. |
1 |
| Cetuximab (7 days) and FOLFIRI (14 days) Therapy. NCCP National SACT Regimen. HSE. |
Treatment of patients with RAS wild type metastatic colorectal cancer. |
1 |
| Cetuximab (7 days) and Irinotecan (14 days) Therapy. NCCP National SACT Regimen. HSE. |
Second line therapy for metastatic colorectal cancer with non-mutated (wild type) RAS after failure of or contraindication to oxaliplatin based therapy. |
1 |
| Cetuximab (14 days) and Irinotecan (14 days) Therapy. NCCP National SACT Regimen. HSE. |
Second line therapy for metastatic colorectal cancer with non-mutated (wild type) RAS after failure of or contraindication to oxaliplatin based therapy. |
1 |
| Panitumumab 6mg/kg and Modified FOLFOX-6 Therapy - 14 day. NCCP National SACT Regimen. HSE. |
First line treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC). |
1 |
| Panitumumab 6mg/kg and FOLFIRI Therapy-14 day. NCCP National SACT Regimen. HSE. |
First line treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC). |
1 |
| Panitumumab 6mg/kg and FOLFIRI Therapy-14 day. NCCP National SACT Regimen. HSE. |
Second line treatment of adult patients with wild-type RAS mCRC who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). |
1 |
| Trastuzumab 5-Fluorouracil and CISplatin Therapy - 21 days. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. |
1 |
| Cetuximab (14 days) and FOLFIRI (14 days) Therapy. NCCP National SACT Regimen. HSE. |
Treatment of patients with RAS wild type metastatic colorectal cancer. |
1 |
| Nivolumab 240mg, CISplatin 80mg/m2 and 5-Fluorouracil Infusional Therapy. NCCP National SACT Regimen. HSE. |
Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression >= 1%. |
1 |
| Nivolumab and FOLFOX-6 Modified Therapy. NCCP National SACT Regimen. HSE. |
Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression >= 1%. |
1 |
| Pembrolizumab 400mg Monotherapy. NCCP National SACT Regimen. HSE. |
First-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a >= 50% tumour proportion score (TPS) with no EGFR mutations or ALK translocations. |
1 |
| Pembrolizumab 400mg Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy whose tumours express PD-L1 with a combined positive score (CPS) >= 10. |
1 |
| Pembrolizumab 400mg Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS >= 1 |
1 |
| Pembrolizumab 400mg Monotherapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of recurrent, or metastatic cervical cancer with disease progression on or after chemotherapy in adults whose tumours express PD-L1 with a CPS >= 1 |
1 |
| Pembrolizumab 400mg Monotherapy. NCCP National SACT Regimen. HSE. |
First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults |
1 |
| Pembrolizumab, PACLitaxel 175mg/m2, CARBOplatin AUC 5 and Bevacizumab Therapy. NCCP National SACT Regimen. HSE. |
Treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS >= 1. |
1 |
| Pembrolizumab, PACLitaxel 175mg/m2 and CARBOplatin AUC 5 Therapy. NCCP National SACT Regimen. HSE. |
Treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS >= 1. |
1 |
| Idelalisib and Ofatumumab Therapy. NCCP National SACT Regimen. HSE. |
In combination with Ofatumumab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. |
3 |
| Midostaurin Maintenance Therapy. NCCP National SACT Regimen. HSE. |
Midostaurin is indicated as single agent maintenance therapy for adult patients with FLT3 mutation positive acute myeloid leukaemia (AML) in complete response after completion of induction and consolidation chemotherapy. |
1 |
| Midostaurin and Intermediate Dose Cytarabine Consolidation Therapy. NCCP National SACT Regimen. HSE. |
Midostaurin is indicated in combination with intermediate dose cytarabine consolidation chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive |
1 |
| Gemcitabine (1250mg/m2) and CISplatin (75mg/m2) Therapy - 21 day. NCCP National SACT Regimen. HSE. |
In combination with nivolumab for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1% (3 cycles only). This combination is available in NCIS (00849.3) |
1 |
| CARBOplatin (AUC 6) and PACLitaxel 200mg/m2 Therapy. NCCP National SACT Regimen. HSE. |
In combination with nivolumab for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1% (3 cycles only). This combination is available in NCIS (00849.1) |
1 |
| Gemcitabine (1000mg/m2) and CARBOplatin (AUC 5) Therapy - 21 day. NCCP National SACT Regimen. HSE. |
In combination with nivolumab for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1% (3 cycles only). This combination is available in NCIS (00849.2) |
1 |
| PEMEtrexed and CISplatin Therapy. NCCP National SACT Regimen. HSE. |
In combination with nivolumab for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1% (3 cycles only). This combination is available in NCIS (00849.5) |
1 |
| PEMEtrexed and CARBOplatin Therapy. NCCP National SACT Regimen. HSE. |
In combination with nivolumab for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1% (3 cycles only). This combination is available in NCIS (00849.4) |
1 |
| Atezolizumab 840mg Monotherapy - 14 Day. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are considered cisplatin ineligible and whose tumours have a PD-L1 expression >= 5%. |
1 |
| Atezolizumab 840mg Monotherapy - 14 Day. NCCP National SACT Regimen. HSE. |
As monotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PDL1 expression >= 50% tumour cells (TC) or >= 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC. |
2 |
| Atezolizumab 840mg Monotherapy - 14 Day. NCCP National SACT Regimen. HSE. |
Adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumours have PD-L1 expression on >= 50% of tumour cells and who do not have EGFR mutant or ALK-positive mutations. |
1 |
| Durvalumab Monotherapy 1500 mg - 28 day. NCCP National SACT Regimen. HSE. |
As monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 >= 1% on tumour cells and whose disease has not progressed following platinum-based chemo-radiation therapy (CRT). |
1 |
| (*riTUXimab) cycloPHOSphamide, DOXOrubicin, vinCRIStine and prednisoLONE (*R)-CHOP) Therapy - 21 days. NCCP National SACT Regimen. HSE. |
Treatment of Non Hodgkins Lymphoma (NHL). Rituximab to be included in CD20 positive patients. |
1 |
| RiTUXimab and Bendamustine Therapy. NCCP National SACT Regimen. HSE. |
Treatment of patients with previously untreated indolent CD20-positive, stage III-IV non-hodgkin lymphoma (NHL). |
1 |
| RiTUXimab and Bendamustine Therapy. NCCP National SACT Regimen. HSE. |
Treatment of patients with previously untreated CD20-positive, stage III-IV mantle cell lymphoma (MCL), ineligible for autologous stem cell transplant. |
1 |
| (R*)-DHAP Therapy. NCCP National SACT Regimen. HSE. |
Treatment of relapsed Non Hodgkin Lymphoma. Rituximab to be included in CD20 positive patients. |
1 |
| Dose Adjusted riTUXimab, Etoposide, prednisoLONE, DOXOrubicin, cycloPHOSphamide and vinCRIStine (DA-R EPOCH) Therapy. NCCP National SACT Regimen. HSE. |
Treatment of patients with CD20 positive diffuse large B-cell Non Hodgkins lymphoma (NHL). |
2 |
| (R*)-ICE ((riTUXimab), Ifosfamide, CARBOplatin and Etoposide) Therapy. NCCP National SACT Regimen. HSE. |
Treatment of relapsed / refractory Non Hodgkin's Lymphoma. Rituximab to be included in CD20 positive patients. |
1 |
| (*riTUXimab) cycloPHOSphamide, DOXOrubicin, vinCRIStine and prednisoLONE (*R)-CHOP Therapy - 14 day. NCCP National SACT Regimen. HSE. |
Treatment of Non Hodgkin's Lymphoma (NHL). Rituximab to be included in CD20 positive patients. |
1 |
| (R*)- miniCHOP Therapy - 21 days. NCCP National SACT Regimen. HSE. |
Treatment of Non Hodgkin Lymphoma in patients aged greater than 80 or with significant co-morbidities. Rituximab to be included in all CD20 positive patients. |
1 |
| R-Gemcitabine (1000mg/m2) Oxaliplatin Therapy - 14 day. NCCP National SACT Regimen. HSE. |
Relapsed or refractory CD20 positive diffuse large B cell lymphoma in patients ineligible for stem cell transplant. |
2 |
| R-CEOP Therapy - 21 days. NCCP National SACT Regimen. HSE. |
Treatment of Non Hodgkin CD20 positive Lymphoma for patients not suitable for anthracycline therapy. |
1 |
| Brentuximab vedotin and Bendamustine Therapy. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL). |
1 |
| riTUXimab 375 mg/m2 Combination Therapy-21 day. NCCP National SACT Regimen. HSE. |
In combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory CD 20 positive patients with follicular lymphoma. |
4 |
| RiTUXimab 375 mg/m2 Maintenance Therapy- 56 day. NCCP National SACT Regimen. HSE. |
Maintenance therapy for the treatment of previously untreated follicular CD20 positive, B-cell Non Hodgkin Lymphoma patients responding to induction therapy. |
2 |
| riTUXimab (S/C 1400mg) Maintenance Therapy-84 day. NCCP National SACT Regimen. HSE. |
Maintenance therapy for the treatment of relapsed/refractory follicular CD20 positive, B-cell Non Hodgkin Lymphoma (NHL) in patients who have responded to induction therapy. |
2 |
| riTUXimab (S/C 1400mg) Maintenance Therapy-56 day. NCCP National SACT Regimen. HSE. |
Maintenance therapy for the treatment of previously untreated follicular CD20 positive, B-cell Non Hodgkin Lymphoma patients responding to induction therapy. |
2 |
| Dose Adjusted riTUXimab S/C, Etoposide, prednisoLONE, DOXOrubicin, cycloPHOSphamide and vinCRIStine. NCCP National SACT Regimen. HSE. |
Treatment of patients with CD20 positive diffuse large B-cell Non Hodgkin's lymphoma (NHL). |
2 |
| riTUXimab, Cyclophosphamide, vinCRIStine and prednisoLONE R-CVP Therapy-21 days. NCCP National SACT Regimen. HSE. |
First line treatment of patients with low grade B cell Non Hodgkin's lymphoma (NHL). Rituximab to be included in CD20 positive patients. |
1 |
| riTUXimab, Cyclophosphamide, vinCRIStine and prednisoLONE R-CVP Therapy-21 days. NCCP National SACT Regimen. HSE. |
Treatment of patients with relapsed/refractory low grade B cell Non Hodgkin's lymphoma (NHL). |
1 |
| RiTUXimab 375 mg/m2 Maintenance Therapy-84 day. NCCP National SACT Regimen. HSE. |
Maintenance therapy for the treatment of relapsed/refractory follicular CD20 positive, B-cell Non Hodgkin Lymphoma (NHL) in patients who have responded to induction therapy. |
2 |
| Imatinib Therapy - GIST. NCCP National SACT Regimen. HSE. |
Treatment of adult patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). |
1 |
| Imatinib Therapy - GIST. NCCP National SACT Regimen. HSE. |
Adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. |
1 |
| Tepotinib Therapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. |
2 |
| Trastuzumab Deruxtecan (Enhertu) Therapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. |
1 |
| Pembrolizumab 400mg, CARBOplatin AUC 5 and weekly PACLitaxel 80mg/m2 followed by Dose Dense DOXOrubicin and cycloPHOSphamide (AC 60/600) Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. |
1 |
| Pembrolizumab 400mg, Weekly CARBOplatin AUC 1.5 and PACLitaxel 80mg/m2 followed by Dose Dense DOXOrubicin and cycloPHOSphamide (AC 60/600) Therapy. NCCP National SACT Regimen. HSE. |
Pembrolizumab in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. |
1 |
| Vandetanib Therapy. NCCP National SACT Regimen. HSE. |
Treatment of medullary thyroid cancer (MTC) in patients with Rearranged during Transfection (RET) mutation positive, unresectable locally advanced or metastatic disease. |
1 |
| Trentinoin (ATRA) and Arsenic Trioxide (ATO) Induction Therapy. NCCP National SACT Regimen. HSE. |
Treatement of patients with newly diagnosed low to intermediate risk Acute Promyelocytic Leukaemia (APL) (defined as WCC count <= 10x10^9/L) |
1 |
| Trentinoin (ATRA) and Arsenic Trioxide (ATO) Induction Therapy. NCCP National SACT Regimen. HSE. |
Treatement of patients with relapsed or refractory APL after ATRA/chemotherapy |
1 |
| Sacituzumab Govitecan Therapy. NCCP National SACT Regimen. HSE. |
As monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease. |
1 |
| Entrectinib Monotherapy - Adult. NCCP National SACT Regimen. HSE. |
For the treatment of adult patients with solid tumors expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who: (i) have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and (ii) who have not received a prior NTRK inhibitor, and (iii) who have no satisfactory treatment options. |
3 |
| Arimidex (anastrozole) [summary of product characteristics]. HPRA. |
Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. |
3 |
| Arimidex (anastrozole) [summary of product characteristics]. HPRA. |
Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women. |
3 |
| Arimidex (anastrozole) [summary of product characteristics]. HPRA. |
Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen. |
3 |
| Anastrozole Monotherapy. NCCP National SACT Regimen. HSE. |
Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen. |
3 |
| Aromasin (exemestane) [summary of product characteristics]. HPRA. |
Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2 – 3 years of initial adjuvant tamoxifen therapy. |
1 |
| Femara (letrozole) [summary of product characteristics]. HPRA. |
Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. |
3 |
| Femara (letrozole) [summary of product characteristics]. HPRA. |
Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years. |
3 |
| Femara (letrozole) [summary of product characteristics]. HPRA. |
First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer. |
3 |
| Femara (letrozole) [summary of product characteristics]. HPRA. |
Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated. |
3 |
| Letrozole Monotherapy. NCCP National SACT Regimen. HSE. |
Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received prior adjuvant endocrine therapy for 5 years. |
3 |
| Letrozole Monotherapy. NCCP National SACT Regimen. HSE. |
Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status. |
3 |