Astellas and Seagen’s Padcev (enfortumab vedotin-ejfv) Receive the US FDA’s Full Approval and Expands Indication for Patients with Locally Advanced or Metastatic Urothelial Cancer

July 12, 2021 Auto Bot regulatory 0

Shots:

  • The approval is based on P-III EV-301 trial evaluating Padcev vs CT in 608 patients with LA or mUC who were previously treated with Pt.-based CT and a PD-1/L1 inhibitor
  • In a pre-specified interim analysis, patients who received Padcev have m-OS (12.9 vs 9.0 mos.) i.e. 3.9mos. longer than those who received CT
  • Padcev is the first and only FDA-approved therapy for UC patients who are cisplatin-ineligible and have previously received one or more prior therapies, based on Cohort 2 of pivotal EV-201 trial. The conversion from accelerated approval to regular approval and the label expansion was based on two sBLAs which is reviewed under RTOR pilot program

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

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