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Astellas’ Padcev Plus Keytruda Receives the EC’s Approval to Treat Advanced Urothelial Cancer

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Astellas’ Padcev Plus Keytruda Receives the EC’s Approval to Treat Advanced Urothelial Cancer

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  • The EC has approved Padcev + Keytruda as a 1L treatment of unresectable or metastatic urothelial cancer (mUC) in adults, eligible for Pt-based CT; Valid across the whole EU plus Iceland, Liechtenstein & Norway
  • Approval was supported by the P-III (EV-302) study assessing the safety & efficacy of Padcev + Keytruda vs Pt-based CT in patients (n=886) with locally advanced mUC
  • Study depicted mOS of 31.5mos. vs 16.1mos., reducing the death risk by 53% & mPFS of 12.5mos. vs 6.3mos. with 55% reduced disease progression or death risk; ~30% of patients received maintenance therapy with avelumab post CT, reflecting real-world practice. Data was highlighted at ESMO 2023 & published in the NEJM

 

Ref: Astellas | Image: Astellas

Related News:- The NMPA Approves Astellas’ Padcev (Enfortumab vedotin) to Treat Adults with Advanced or Metastatic Urothelial 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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