Posted by Michael Wonder on 13 Apr 2022
European Commission approves Padcev (enfortumab vedotin) for locally advanced or metastatic urothelial cancer
13 April 2022 - Enfortumab vedotin is the first medicine approved in the EU for patients who received a prior platinum-containing chemotherapy and a PD-1/L1 inhibitor.
Astellas and Seagen today announced that the European Commission has approved Padcev (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor.
The European Commission approval is supported by data from the global Phase 3 EV-301 trial that demonstrated an overall survival benefit compared with chemotherapy.
