Regulatory approval

Published by the European Medicines Agency. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	MSI-H	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab
EMA (1)	dMMR	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab

Contributions

Date	Contributor	Description
2025-09-05	Van Allen lab	On 2025-01-13, the EMA published an EPAR - Assessment report - Variation for Yervoy (ipilimumab) that added an extension indication to 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.
2024-12-19	European Medicines Agency	Indication received approval from the European Commission.