Regulatory approval

Published by the Health Canada.

Health Canada approved pembrolizumab as a monotherapy for the treatment of adult patients with metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by a validated test.

This is written in the approval document as:

KEYTRUDA (pembrolizumab) is indicated, as monotherapy, for the treatment of adult patients with metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by a validated test.

Citation

Merck Canada Inc. Keytruda (pembrolizumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083378.PDF. Published January 2026. Accessed April 2026.

Therapeutic response

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

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HC (1)	dMMR	Colorectal Adenocarcinoma	Pembrolizumab
HC (1)	MSI-H	Colorectal Adenocarcinoma	Pembrolizumab