BMS’ Opdivo(nivolumab) Receives the US FDA’s Approval for the Adjuvant Treatment of High-Risk Urothelial Carcinoma

August 23, 2021 Auto Bot regulatory 0

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

Click here to­ read full press release/ article | Ref: BMS | Image: TAPinto

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