Shots:

• The approval is based on the P-III CheckMate -274 trial evaluating Opdivo (240mg- IV- q2w- for ~1 yrs.) vs PBO in a ratio (1:1) in 709 patients with UC who are at high risk of recurrence after undergoing radical resection
• The results showed a 30% reduction in the risk of disease recurrence or death- m-DFS (20.8 vs 10.8mos.) in the ITT population. Additionally- m-DFS (not reached vs 8.4mos.) among patients whose tumors express PD-L1 ≥1% with a 45% reduction in risk of disease recurrence or death
• The application was approved under the FDA’s RTOR pilot program. The results further support the conversion of Opdivo’s accelerated approval to regular approval

  Ref: BMS | Image: BMS