Posted by Michael Wonder on 11 Feb 2020
U.S. FDA grants priority review for Kite’s KTE-X19 biologics license application in relapsed or refractory mantle cell lymphoma
10 February 2020 - If approved, Kite could be first company with multiple commercialised CAR T therapies.
Kite, today announced that the U.S. FDA has accepted the biologics license application and granted priority review designation for KTE-X19, an investigational chimeric antigen receptor T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
The application is supported by data from the single arm, open-label, Phase 2 ZUMA-2 trial, which showed that 93% of patients responded to a single infusion of KTE-X19, including 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee (median follow-up of 12.3 months).
