Astellas and Seagen Report EMA’s Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer

March 26, 2021 Auto Bot Acceptance, Advanced, Astellas, EMA, MAA, Metastatic, regulatory, Report, Seagen, Treat, Urothelial Cancer 0

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

The post Astellas and Seagen Report EMA’s Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer first appeared on PharmaShots.