FDA accepts BLA for enfortumab vedotin to treat bladder cancer.- Seattle Genetics.

Seattle Genetics, Inc announced that the FDA has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin and granted Priority Review for the treatment of patients with locally advanced or metastatic urothelial cancer ( bladder cancer) who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

The filing is based on results from the first cohort of patients in the EV-201 pivotal phase II clinical trial that were presented as a late-breaking oral presentation at the annual meeting of the American Society of Clinical Oncology ( ASCO ) in June 2019. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of 15 March 2020 .

Enfortumab vedotin is a novel investigational antibody-drug conjugate (ADC) that targets Nectin-4, a protein that is highly expressed in urothelial cancers1 .The FDA granted enfortumab vedotin Breakthrough Therapy designation in March 2018 , for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following checkpoint inhibitor therapy.