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Astellas’ Padcev (enfortumab vedotin) Receives EC’s Approval for the Treatment of Locally Advanced or Metastatic Urothelial Cancer

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Astellas’ Padcev (enfortumab vedotin) Receives EC’s Approval for the Treatment of Locally Advanced or Metastatic Urothelial Cancer

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  • The approval was based on the P-III (EV-301) trial evaluating enfortumab vedotin vs CT (docetaxel, paclitaxel, or vinflunine) in 608 patients with LA or metastatic urothelial cancer prior treated with PD-1/L1 inhibitor & Pt-based therapies. The therapy is co-developed by Astellas & Sagen
  • The results showed an improvement in OS & 2EPs are PFS, ORR, DoR & DCR, along with safety/tolerability & QoL. In the pre-specified interim analysis, patients who received enfortumab vedotin lived in a median of 3.9mos., m-OS (12.9 vs 9mos.)
  • The results support the global registrations for enfortumab vedotin. The marketing authorization is valid in the EU Member States, Iceland, Norway & Liechtenstein

Ref: Businesswire | Image: Astellas

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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