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/00080285.PDF. Published April 2025. Accessed June 2025.

Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) dMMR Colorectal Adenocarcinoma Pembrolizumab
Sensitivity (+) MSI-H Colorectal Adenocarcinoma Pembrolizumab