FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer

FDA

10 July 2021 - On 9 July 2021, the FDA approved enfortumab vedotin-ejfv (Padcev), for adult patients with locally advanced or metastatic urothelial cancer who

  • Have previously received a programmed death receptor-1 or programmed death-ligand inhibitor and platinum-containing chemotherapy, or
  • Are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

The FDA granted accelerated approval in December 2019 to enfortumab vedotin-ejfv for patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Read FDA press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US