Regulatory approval

Published by the European Medicines Agency. Approved

Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.

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)	ER positive, HER2-positive, PR positive	Invasive Breast Carcinoma	Anastrozole, Trastuzumab
EMA (1)	ER positive, HER2-positive	Invasive Breast Carcinoma	Anastrozole, Trastuzumab
EMA (1)	ER positive, ERBB2 amplification, PR positive	Invasive Breast Carcinoma	Anastrozole, Trastuzumab
EMA (1)	ER positive, ERBB2 amplification	Invasive Breast Carcinoma	Anastrozole, Trastuzumab
EMA (1)	ERBB2 amplification, PR positive	Invasive Breast Carcinoma	Anastrozole, Trastuzumab
EMA (1)	HER2-positive, PR positive	Invasive Breast Carcinoma	Anastrozole, Trastuzumab