Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized Phesgo (pertuzumab / trastuzumab) in combination with chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on APHINITY (BO25126), a multicenter, randomized, double-blind, and placebo-cotrolled phase 3 trial conducted in 4804 patients with HER2-positive early breast cancer. Within this trial, investigators had the choice of one of the following chemotherapy regimens: 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 paclitaxell; 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; or 6 cycles of docetaxel in combination with carboplatin.
This is written in the approval document as:
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.
Citation
Roche Registration GmbH. Phesgo (pertuzumab / trastuzumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf. Revised March 2022. Accessed March 22, 2024.Therapeutic 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, Epirubicin, Fluorouracil, Pertuzumab, Trastuzumab | |
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Cyclophosphamide, Epirubicin, Fluorouracil, Paclitaxel, Pertuzumab, Trastuzumab | |
| 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 |