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