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

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: FDA Reporter