Astellas : FDA Approves Padcev For Metastatic Urothelial Cancer

(RTTNews) - Astellas Pharma Inc. and Seattle Genetics Inc. (SGEN) said that the U.S. Food and Drug Administration granted accelerated approval to Padcev for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic setting.

PADCEV is approved under the FDA's Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.