Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized trastuzumab as a monotherapy for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) that have received at least two chemotherapy regimes for their metastatic disease. Prior chemotherapy must have been included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must have also failed hormonal therapy, unless a patient is unsuitable for those treatments. 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) as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.

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	Trastuzumab
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Trastuzumab