Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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