Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

April 20, 2021 Auto Bot Acceptance, Advanced, Astellas, FDA, Metastatic, regulatory, reports, Review, sBLA, Seagen, Two, Urothelial Cancer 0

Shots:

  • The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated with PD-1/L1 inhibitor and platinum-based therapy. The first sBLA seeks to convert PADCEV’s accelerated approval to regular approval
  • The second sBLA is based on cohort 2 of the P-II EV-201 trial evaluating Padcev in 91 patients with LA or mUC who have been previously treated with PD-1 or PD-L1 inhibitor and are ineligible for cisplatin. It requests an expansion of the current indication
  • The submissions will be reviewed under Project Orbis for both the trials and results were presented at ASCO GU’ 2021. The target action date for both applications is Aug 17, 2021

Click here to­ read full press release/ article | Ref: Astellas | Image: Nasdaq

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