Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized trastuzumab in combination with docetaxel for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) that have not received chemotherapy for their metastatic disease. 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 metastatic breast cancer (MBC) in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.

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	Docetaxel, Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Docetaxel, Trastuzumab