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 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