BMS' latest Opdivo submission validated by EMA
US drugmaker Bristol Myers Squibb (NYSE: BMY) has announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.
The application is based on results from CheckMate -274, the first positive Phase III trial of an immunotherapy in this setting, which demonstrated increased disease-free survival with Opdivo versus placebo, regardless of patients’ PD-L1 expression levels.
Opdivo was generally well tolerated in the trial, with a safety profile that was consistent with previously-reported studies in patients with solid tumors.
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