Posted by Michael Wonder on 16 Sep 2019
Seattle Genetics and Astellas announce U.S. FDA grants priority review for enfortumab vedotin biologics license application in locally advanced or metastatic urothelial cancer
16 September 2019 - FDA sets Prescription Drug User Fee action date for 15 March 2020.
Seattle Genetics and Astellas Pharma today announced that the U.S. FDA has accepted the biologics license application for the investigational agent enfortumab vedotin and granted priority review 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 neo-adjuvant/adjuvant, locally advanced or metastatic setting.
The filing is based on results from the first cohort of patients in the EV-201 pivotal phase 2 clinical trial that were presented as a late-breaking oral presentation at the annual meeting of the American Society of Clinical Oncology in June 2019.
