Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration (FDA) granted approval to nivolumab in combination with ipilimumab for the first-line 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.

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 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.

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Ipilimumab, Nivolumab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2020-05-15	Food and Drug Administration	Indication received traditional approval.