Regulatory approval

Published by the Health Canada. Approved

KEYTRUDA (pembrolizumab) is indicated as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	dMMR	Any solid tumor	Pembrolizumab
HC (1)	MSI-H	Any solid tumor	Pembrolizumab