Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved gemtuzumab ozogamicin in combination with daunorubicin and cytarabine for reimbursement as a treatment option for the treatment of patients aged 15 years and above with previously untreated, de novo CD33 positive Acute Myeloid Leukemia (AML), except acute promyelocytic leukemia.
This is written in the approval document as:
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
Citation
Gemtuzumab ozogamicin DAUNOrubicin and cytarabine Therapy (AML induction), 2023, version number 2, NCCP National SACT Regimen, NCCP, viewed 04/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/612-gemtuzumab-ozogamicin-therpay.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | CD33 + | Acute Lymphoid Leukemia | Cytarabine, Daunorubicin, Gemtuzumab ozogamicin |