Astellas and Seattle Genetics’ Padcev Earns Breakthrough Designation for Bladder Cancer

Astellas and Seattle Genetics received the FDA’s breakthrough therapy designation for Padcev (enfortumab vedotin-ejfv) in combination with Merck's Keytruda (pembrolizumab) to treat patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

The designation was granted based on results of a phase 1b/2 trial evaluating patients with locally advanced or metastatic urothelial cancer unable to receive cisplatin-based chemotherapy treated with Padcev in combination with pembrolizumab.

Padcev was previously granted accelerated approval to treat 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.