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