![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Astellas and Seattle Genetics’ Padcev Gets Accelerated Approval for Urothelial Cancer
Astellas and Seattle Genetics’ Padcev Gets Accelerated Approval for Urothelial Cancer
January 3, 2020
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.
Upcoming Events
-
21Oct