Regulatory approval

Published by the Food and Drug Administration. Approved

OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adult patients with resectable (tumors >=4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery.

This is written in the approval document.

Citation

Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf. Revised April 2025. Accessed April 30, 2025.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Nivolumab, Paclitaxel
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Nivolumab, Pemetrexed
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Gemcitabine, Nivolumab