Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that dMMR status confers therapeutic sensitivity to Ipilimumab, Nivolumab in patients with Colorectal Adenocarcinoma.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.