Regulatory approval

Published by the Health Canada. Approved

Health Canada approved trastuzumab in combination with capecitabine or intravenous 5-fluorouracil and cisplatin for the treatment of HER2-positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction in patients who have not received prior anti-cancer treatment for metastatic disease.

This is written in the approval document as:

HERCEPTIN (trastuzumab for injection) in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is indicated for the treatment of 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.

Citation

Hoffmann-La Roche Limited. Herceptin (trastuzumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080472.PDF. Revised May 2025. Accessed June 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies

Contributions

Date	Contributor	Description