Regulatory approval

Published by the European Medicines Agency. Approved

OPDIVO in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.

This is written in the approval document.

Citation

Bristol-Myers Squibb Pharma EEIG. Opdivo (nivolumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf. Revised June 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
2025-09-04	Van Allen lab	On 2025-01-13, the EMA published an EPAR - Assessment report - Variation for Opdivo (nivolumab) for that added an extension indication to nivolumab in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
2024-12-19	European Medicines Agency	Indication received approval from the European Commission.