Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized trastuzumab in combination with paclitaxel or docetaxel for the treatment of adult patients with HER2 positive early breast cancer (EBC) following adjuvant chemotherapy with doxorubicin and cyclophosphamide. The production information for trastuzumab notes that trastuzumab should only be used in patients with metastatic or early breast cancer whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
This is written in the approval document as:
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.
Citation
Roche Registration GmbH. Herceptin (trastuzumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf. Revised March 2023. Accessed March 12, 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 | Paclitaxel, Trastuzumab | |
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Docetaxel, Trastuzumab | |
| Sensitivity (+) | ERBB2 amplification | Invasive Breast Carcinoma | Paclitaxel, Trastuzumab | |
| Sensitivity (+) | ERBB2 amplification | Invasive Breast Carcinoma | Docetaxel, Trastuzumab |