Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved pertuzumab in combination with trastuzumab and chemotherapy partially for reimbursement as a treatment option for the adjuvant treatment of adult patients with HER2-positive breast cancer at high risk of recurrence. The therapy regimen states that pertuzumab is not currently approved for reimbursement for this indication, and that trastuzumab and chemotherapy are available for reimbursement through the hospital scheme. According to the EMA product information for this indication, this indication is based on APHINITY (BO25126), a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. Investigators selected one of the following chemotherapy regimes: (i) 3 or 4 cycles of FEC or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; (ii) 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; or (iii) 6 cycles of docetaxel in combination with carboplatin.
This is written in the approval document as:
Pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of adult patients with HER2-positive breast cancer at high risk of recurrence.
Citation
Pertuzumab and Trastuzumab and Chemotherapy Therapy - 21 day cycle, 2023, version number 3, NCCP National SACT Regimen, NCCP, viewed 01/09/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/350%20pertuzumab%20and%20trastuzumab%20and%20chemotherapy.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Cyclophosphamide, Docetaxel, Doxorubicin, Fluorouracil, Pertuzumab, Trastuzumab | |
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Cyclophosphamide, Doxorubicin, Fluorouracil, Paclitaxel, Pertuzumab, Trastuzumab | |
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Cyclophosphamide, Docetaxel, Epirubicin, Pertuzumab, Trastuzumab | |
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Cyclophosphamide, Epirubicin, Paclitaxel, Pertuzumab, Trastuzumab | |
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Carboplatin, Docetaxel, Pertuzumab, Trastuzumab |