BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma

April 30, 2021 Auto Bot BMS, FDA, Nivolumab, Opdivo, Priority Review, regulatory, sBLA 0

Shots:

  • The filing is based on results from the P-III CheckMate -274 trial evaluating Opdivo (240mg, q2w for up to 1 yrs.) vs PBO in a ratio (1:1) in 709 patients with muscle-invasive urothelial cancer who are at a high risk of recurrence after radical surgery
  • The study demonstrated the improvement in DFS regardless of patients’ PD-L1 expression levels, therapy was well-tolerated with a consistent safety profile in previously reported studies in patients with solid tumors
  • If approved, Opdivo will be the first adjuvant immunotherapy option for patients with muscle-invasive urothelial carcinoma in the US. The FDA granted Priority Review with an anticipated PDUFA date as of Sept 3, 2021

Click here to­ read full press release/ article | Ref: Businesswire | Image: Twitter

The post BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma first appeared on PharmaShots.