Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized nivolumab as a monotherapy for the adjuvant treatment of adult patients with muscle invasive urothelial carcinoma (MIUC) with tumor cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.

This is written in the approval document as:

OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.

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)	PD-L1 >= 1%	Bladder Urothelial Carcinoma	Nivolumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-04-01	European Medicines Agency	Indication received approval from the European Commission.