Regulatory approval

Published by the Health Canada. Approved

KEYTRUDA (pembrolizumab) as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung carcinoma (NSCLC) or stage III disease where patients are not candidates for surgical resection or definitive chemoradiation, expressing PD-L1 [Tumour Proportion Score (TPS) >= 1%] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations.

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)	PD-L1 >= 1%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals