Regulatory approval

Published by the European Medicines Agency.

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 March 2024. Accessed March 22, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 1%	Bladder Urothelial Carcinoma	Nivolumab