Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized docetaxel in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors over express HER2 and who previously have not received chemotherapy for metastatic disease.
This is written in the approval document as:
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.
Citation
Sanofi Winthrop Industrie. Taxotere (docetaxel) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/taxotere-epar-product-information_en.pdf. Revised December 2023. Accessed March 11, 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 | Docetaxel, Trastuzumab | |
| Sensitivity (+) | ERBB2 amplification | Invasive Breast Carcinoma | Docetaxel, Trastuzumab |