Regulatory approval

Published by the Health Canada. Approved

OPDIVO (nivolumab) in combination with ipilimumab, is indicated for the treatment of adult patients with metastatic NSCLC, expressing PD-L1 >= 1% as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic therapy for metastatic NSCLC.

This is written in the approval document.

Citation

Bristol-Myers Squibb Canada. Opdivo (nivolumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083469.PDF. Revised February 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	Ipilimumab, Nivolumab

Contributions

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