Regulatory approval

Published by the Health Canada. Approved

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.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
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

Contributions

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