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Seattle Genetics, Astellas Submit BLA For Enfortumab Vedotin - Quick Facts

Seattle Genetics, Inc. (SGEN) and Astellas Pharma Inc. (ALPMY,ALPMY) have submitted a Biologics License Application to the U.S. FDA for the accelerated approval of Enfortumab Vedotin for patients with locally advanced or metastatic urothelial cancer.

Enfortumab vedotin, an investigational antibody-drug conjugate, targets Nectin-4, a protein that is highly expressed in urothelial cancers. The BLA submission was based on results from the first cohort of patients in the EV-201 phase 2 trial. Based on preliminary results from a phase 1 trial, the FDA previously granted enfortumab vedotin Breakthrough Therapy designation.

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