Opdivo (nivolumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s080lbl.pdf. Revised May 2020. Accessed October 6, 2026.

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 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

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Ipilimumab, Nivolumab