Opdivo (nivolumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s127lbl.pdf. Revised October 2024. Accessed October 6, 2026.

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Regulatory approvals

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

Indication Statements
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. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
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