FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer

On 9 July 2021, the US Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, by Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who

• have previously received a PD1 or PD-L1 inhibitor and platinum-containing chemotherapy, or
• are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

Evidence is based on the results from the EV-301 study that was required to confirm the clinical benefit assessed as part of the accelerated approval granted on the December 18, 2019.

link