Libtayo (cemiplimab) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
LIBTAYO (cemiplimab for injection) is indicated as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.	2
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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	Wild type ALK, Wild type EGFR, Wild type ROS1	Non-Small Cell Lung Cancer	Carboplatin, Cemiplimab, Pemetrexed
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR, Wild type ROS1	Non-Small Cell Lung Cancer	Cemiplimab