KTE-X19 marketing authorization application fully validated by the EMA

On 28 January 2020, the Marketing Authorization Application (MAA) for KTE-X19, a chimeric antigen receptor (CAR) T-cell therapy, was fully validated by the European Commission  for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). Authorization is currently under evaluation by the European Medicines Agency (EMA).¹

The MAA was based on encouraging data from the single arm, open-label, phase II ZUMA-2 trial (NCT02601313) evaluating the efficacy of KTE-X19 in subjects with R/R MCL. With a median follow-up of 12.3 months, the study demonstrated an overall response rate of 93%, with 67% of patients in complete response following a single infusion of KTE-X19.²

KTE-X19 is an investigational, autologous, anti-CD19 CAR T-cell therapy containing CD3ζ signaling and CD28 costimulatory domains.³ KTE-X19 has previously been granted Priority Medicines (PRIME) by the EMA, Breakthrough Therapy Designation by the U.S. Food & Drug Administration  and is currently in phase I/II trials in acute lymphoblastic leukemia (NCT02614066), MCL (NCT04162756) and chronic lymphocytic leukemia (NCT03624036).

If approved, KTE-X19 will be the first CAR T-cell therapy for the treatment of MCL. Read coverage of results from the ZUMA-2 trial presented at the American Society of Hematology 2019 Annual Meeting & Exposition here.