European Medicines Agency validates Marketing Authorisation Application CAR-T cell therapy, KTE-X19 for treatment of adults with relapsed or refractory mantle cell lymphoma

The Marketing Authorisation Application for this investigational chimeric antigen receptor CAR-T cell therapy is supported by data from the single arm, open-label, phase II ZUMA-2 trial, which demonstrated an overall response rate of 93% and a 67% complete response rate.