FDA has accepted Biological License Application submitted by Kite for its CAR-T cell therapy- KTE-X19, for relapsed or refractory mantle cell lymphoma (MCL)
The drug- KTE-X19, which is an investigational chimeric antigen receptor (CAR) T cell therapy treatment method for curing relapsed or refractory mantle cell lymphoma (MCL), has received a Priority Review designation.
The recommendation came after the data from the single arm, open-label, Phase 2 ZUMA-2 trial, which revealed 93 percent 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 Com...
