Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	HER2-positive	Invasive Breast Carcinoma	Docetaxel, Trastuzumab
EMA (1)	ERBB2 amplification	Invasive Breast Carcinoma	Docetaxel, Trastuzumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
1995-11-27	European Medicines Agency	Indication received approval from the European Commission.