Seattle Genetics + Astellas submit a BLA to the FDA for accelerated approval for enfortumab vedotin for metastatic urothelial cancer.

Seattle Genetics, Inc. and Astellas Pharma Inc. announced submission of a Biologics License Application for accelerated approval to the FDA for the investigational agent enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial 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 submission 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 abstract at the annual meeting of the American Society of Clinical Oncology ( ASCO ) in June. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a protein that is highly expressed in urothelial cancers.