Regulatory approval

Published by the Health Canada.

Health Canada approved pembrolizumab 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 as:

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.

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