Posted by Michael Wonder on 12 Dec 2019
Kite submits biologics license application to U.S. FDA for Company’s second CAR T cell therapy
11 December 2019 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma if approved.
Kite today announced that it has submitted a biologics license application to the U.S. FDA for the investigational chimeric antigen receptor T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
The submission is based on data from the Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93%, including 67% with complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of KTE-X19.
