Opdivo (nivolumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

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
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>= 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab.	1
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.	3
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.	2
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Ipilimumab, Nivolumab
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
Sensitivity (+)	MSI-H	Colorectal Adenocarcinoma	Nivolumab
Sensitivity (+)	dMMR	Colorectal Adenocarcinoma	Nivolumab
Sensitivity (+)	MSI-H	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab
Sensitivity (+)	dMMR	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab