Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized ipilimumab in combination with nivolumab for the first-line treatment of adult patients with mismatch repair deficient or microsatellite instability-high unresectable or metastatic colorectal cancer.

This is written in the approval document as:

YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with mismatch repair deficient or microsatellite instability-high unresectable or metastatic colorectal cancer.

Citation

Bristol-Myers Squibb Pharma EEIG. Yervoy (ipilimumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf. Revised March 2025. Accessed September 5, 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