Astellas and Seattle Genetics’ Padcev Gets Accelerated Approval for Urothelial Cancer

The FDA granted accelerated approval to Astellas and Seattle Genetics’ Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.

Padcev was approved based on the results of a clinical trial of 125 patients who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy, of which 44 percent had some tumor shrinkage.

The agency previously granted Padcev priority review and breakthrough therapy designations. As a condition of its accelerated approval, the FDA required a further clinical trial to verify and describe its clinical benefit.