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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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