Posted by Michael Wonder on 29 Jan 2020
European Medicines Agency validates Kite’s marketing application for company’s second CAR T cell therapy
28 January 2020 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma in Europe if approved.
Kite today announced that the company’s marketing authorisation application for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, has been fully validated and is now under evaluation by the European Medicines Agency.
The application is supported by data from the single arm, open-label, Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of KTE-X19 (median follow-up of 12.3 months).
