The NMPA Approves Astellas’ Padcev (Enfortumab vedotin) to Treat Adults with Advanced or Metastatic Urothelial Cancer
Shots:
- The NMPA has approved Padcev to treat individuals with locally advanced or metastatic urothelial cancer (la/mUC) following prior therapy with Pt-containing CT & PD-1 or PD-L1 inhibitors.
- The approval was based on the P-III (EV-301; globally) and P-II (EV-203; China) study evaluating the safety, efficacy & PK of enfortumab vedotin in adults who had earlier been treated with a PD-1/PD-L1 inhibitor and Pt-based CT
- The study reached its 1EP and showed significant improvement in ORR and OS adults who received enfortumab vedotin (alone) vs historical controls by the independent review committee. The company has incorporated the effects of enfortumab vedotin's approval in China into its financial projections for the fiscal year ending March 31, 2025.
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