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

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