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
Organizations Biomarkers Cancer types Therapies
FDA (2) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Nivolumab, Paclitaxel
FDA (2) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Nivolumab, Pemetrexed
FDA (2) 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
2024-10-03 Food and Drug Administration Indication received traditional approval.