Priority Review for Bristol Applicatioon for Opdivo Combo for Urothelial Cancer

Application based on results from the Phase 3 CheckMate -901 trial showing significant survival improvement vs. standard-of-care gemcitabine plus cisplatin in cisplatin-eligible patients with untreated, unresectable or metastatic urothelial carcinoma

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the U.S.

The U.S. Food and Drug Administration assigned a target action date of April 5, 2024

https://finance.yahoo.com/news/u-food-drug-administration-accepts-115900435.html