Astellas and Seagen Report EMA's Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer
Shots:
- The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC- prior treated with Pt.-based CT and a PD-1/L1 inhibitor
- The 1EPs of the trial is OS and 2EPs include PFS- ORR- DoR- DCR as well as the assessment of safety/tolerability and QoL parameters
- If approved- Enfortumab Vedotin will be the 1st ADC available in the EU for UC. The MAA requests review of Enfortumab Vedotin under accelerated assessment for LA/M-UC
Ref: BusinessWire | Image: Astellas
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