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

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

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