Regulatory approval

Published by the European Medicines Agency. Approved

Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

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	Esophagogastric Adenocarcinoma	Capecitabine, Cisplatin, Trastuzumab
EMA (1)	HER2-positive	Esophagogastric Adenocarcinoma	Cisplatin, Fluorouracil, Trastuzumab
EMA (1)	ERBB2 amplification	Esophagogastric Adenocarcinoma	Capecitabine, Cisplatin, Trastuzumab
EMA (1)	ERBB2 amplification	Esophagogastric Adenocarcinoma	Cisplatin, Fluorouracil, Trastuzumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2010-01-19	European Medicines Agency	Indication received approval from the European Commission.