Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to nivolumab in combination with platinum-doublet chemotherapy for the neoadjuvant treatment, followed by single-agent nivolumab as adjuvant treatment after surgery, of adult patients with resectable (tumors >= 4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements. This indication is based on CHECKMATE-816 (NCT02998528), a randomized, open label trial where patients received either: carboplatin with paclitaxel for either histology, cisplatin with pemetrexed for non-squamous histology, or cisplatin with gemcitabine for squamous histology.

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 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.

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, Nivolumab, Paclitaxel
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Nivolumab, Pemetrexed
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Gemcitabine, Nivolumab