BMS Opdivo Adjuvant Treatment of Muscle Invasive Urothelial Carcinoma Approved in Europe

CompileKe Ke

On March 29, Bristol-Myers Squibb (BMS) announced that the European Medicines Agency (EMA) has confirmed the type II variant application of Opdivo (nivolumab) to use the drug for surgical removal of high-risk muscle invasive urothelial cancer.

The confirmation of the application indicates that the submission of drug indications has been completed and the centralized review process of EMA has begun.

According to reports, this application is based on the results of the trial CheckMate-274, a phase 3 randomized, double-blind, multi-center clinical study that assessed the risk of recurrence of Opdivo and placebo after radical resection of muscle invasive urothelial cancer.

CheckMate-274 is the first positive phase 3 trial of immunotherapy for patients with surgically removed high-risk muscle-invasive urothelial carcinoma.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, designed to uniquely use the body's own immune system to help restore the anti-tumor immune response, and fight cancer by using the body's own immune system.

Reference source: European Medicines Agency Validates Bristol Myers Squibb's Application for Opdivo (nivolumab) as Adjuvant Treatment for Patients with Muscle-Invasive Urothelial Carcinoma