Regulatory approval

Published by the Health Canada.

Health Canada approved nivolumab in combination with platinum-doublet chemotherapy, the neoadjuvant treatment of adult patients with resectable Stage II (>4 cm), IIIA, IIIB (T3-4N2) NSCLC and no known epidermal growth factor Opdivo (nivolumab) receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by OPDIVO as a single agent in the adjuvant setting after surgical resection. This approval is based on CHECKMATE-816, a randomized, open label trial where patients were offered platinum-doublet chemotherapy consisting of either paclitaxel and carboplatin; pemetrexed and cisplatin for non-squamous histology; or gemcitabine and cisplatin for squamous histology.

This is written in the approval document as:

OPDIVO (nivolumab), in combination with platinum-doublet chemotherapy, the neoadjuvant treatment of adult patients with resectable Stage II (>4 cm), IIIA, IIIB (T3-4N2) NSCLC and no known epidermal growth factor Opdivo (nivolumab) receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by OPDIVO as a single agent in the adjuvant setting after surgical resection.

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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HC (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Nivolumab, Paclitaxel
HC (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Nivolumab, Pemetrexed
HC (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Gemcitabine, Nivolumab