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FULL APPROVALS

Padcev Receives Regular FDA Approval for Locally Advanced or Metastatic Urothelial Cancer

Web Exclusives - FDA Updates

On July 9, 2021, the FDA granted full approval to enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have received ≥1 previous lines of therapy. The FDA granted initial accelerated approval to enfortumab vedotin for this indication in December 2019.

The current regular FDA approval of enfortumab vedotin for this indication was based on the results of the EV-301 clinical trial, an open-label, randomized, multicenter study that was conducted to further confirm the clinical benefit of enfortumab vedotin for this indication, as part of the requirements of the initial accelerated approval.

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