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BMS’ Opdivo Plus Cisplatin and Gemcitabine Gain EC’s Approval for Treating Urothelial Carcinoma 

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  • The EC has approved Opdivo + cisplatin & gemcitabine as 1L treatment of unresectable or metastatic urothelial carcinoma (UC) adults, valid across the whole EU along with Iceland, Liechtenstein & Norway, based on the P-III (CheckMate -901) study 
  • The P-III (CheckMate -901) study assessed Opdivo + Yervoy or Opdivo + cisplatin & gemcitabine followed by Opdivo alone vs SoC CT alone to treat unresectable or metastatic urothelial cancer patients (n=608) 
  • The results, with a median follow-up of 33mos., depicted 22% OS with mOS of 21.7mos. vs 18.9mos.; 28% PFS with mPFS of 7.9mos. vs 7.6mos.; 57.6% (n=175) vs 43.1% (n=131) ORR with CR [22% (n=66) vs 12% (n=36)] and PR [36% (n=109) vs 31% (n=95)]. Results were highlighted at ESMO 2023 

Ref: BMS | Image:BMS | Press Release

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