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 metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy.

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.

View API

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, Ipilimumab, Nivolumab, Pemetrexed
FDA (2) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Ipilimumab, Nivolumab, Pemetrexed
FDA (2) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Ipilimumab, Nivolumab, Paclitaxel

Contributions

Date Contributor Description
2025-05-26 Food and Drug Administration Indication received traditional approval.
2024-10-30 Van Allen lab Initial access of FDA approvals
2020-05-26 Food and Drug Administration Indication received accelerated approval.