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

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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

Related News:- BMS Reports the Updated Data from P-III (CheckMate -73L) Study of Opdivo for Non-Small Cell Lung Cancer

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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