Regulatory approval

Published by the European Medicines Agency. Approved

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

This is written in the approval document as:

YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.

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
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-06-24	European Medicines Agency	Indication received approval from the European Commission.