Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized trastuzumab in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab for the treatment of adult patients with HER2 positive early breast cancer (EBC) whose tumors are locally advanced (including inflammatory) disease or > 2 cm in diameter. This indication is based on the multicenter randomized trial MO16432 which used doxorubicin in combination with paclitaxel for the neoadjuvant chemotherapy. 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) in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.

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.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2011-12-19	European Medicines Agency	Indication received approval from the European Commission.