FDA Grants Priority Review For Kite's KTE-X19 BLA

Kite, a Gilead Co. (GILD), said that the U.S. Food and Drug Administration has accepted the Biologics License Application and granted Priority Review designation for KTE-X19, an investigational chimeric antigen receptor or CAR T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma or MCL. The Prescription Drug User Fee Act, or target action date, is August 10, 2020.