Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) granted approval to nivolumab in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This indication is based on CHECKMATE-9LA (NCT03215706), a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.

This is written in the approval document as:

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.

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.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Ipilimumab, Nivolumab, Pemetrexed
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Ipilimumab, Nivolumab, Pemetrexed
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Ipilimumab, Nivolumab, Paclitaxel