FDA Approval Sought for KTE-X19 in Relapsed/Refractory Mantle Cell Lymphoma

December 12, 2019 – A biologics license application has been submitted to the FDA for the investigational CAR T-cell therapy KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma (MCL). The application is based on findings from the phase II ZUMA-2 trial, which were recently presented at the 2019 ASH Annual Meeting.2 Results showed a single infusion of KTE-X19 elicited an overall response rate (ORR) of 93%, as well as a complete … (leggi tutto)