Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Nivolumab in patients with Bladder Urothelial Carcinoma.

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

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.

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.