Regulatory approval

Published by the Health Canada.

Health Canada approved cemiplimab in cominbation with platinum-based chemotherapy for the first‐line treatment of adult patients with NSCLC whose tumors have no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.

This is written in the approval document as:

LIBTAYO (cemiplimab for injection) in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with NSCLC whose tumors have no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.

Citation

Regeneron Canada Company. Libtayo (cemiplimab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078455.PDF. Revised January 2025. Accessed June 2025.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)