Yervoy (ipilimumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Bristol-Myers Squibb Company. Yervoy (ipilimumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125377s133lbl.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
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in combination with nivolumab.	2
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for 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 nivolumab.	1
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for 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 nivolumab and 2 cycles of platinum-doublet chemotherapy.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	MSI-H	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab
Sensitivity (+)	dMMR	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab
Sensitivity (+)	PD-L1 >= 1%, Wild type ALK, Wild type EGFR	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