Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to ipilimumab in combination with nivolumab for the 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.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	MSI-H	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab
Sensitivity (+)	dMMR	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab