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Marketing Authorization Application has been submitted to the EMA for Kite’s KTE-C19

Aug 2, 2017

On 31st July 2017, the European Medicines Agency (EMA) received a Marketing Authorization Application (MAA) from Kite Pharma for KTE-C19 (axicabtagene ciloleucel) for patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL), transformed Follicular Lymphoma (tFL), and Primary Mediastinal B-Cell Lymphoma (PMBCL) who are not eligible for Autologous Stem Cell Transplant (ASCT).

KTE-C19 is the first Chimeric Antigen Receptor (CAR) T-cell therapy to be submitted to the EMA. In May of this year, KTE-C19 was granted Priority Review by the U.S. Food and Drug Administration (FDA; read more here) and is expected to make a decision on 29th November 2017.

The MAA submission included data from the phase II ZUMA-1 trial (NCT02348216). Primary results from this study were initially presented by Frederick L. Locke at AACR 2017 (view here), then by Sattva S. Neelapu at ICML 2017 (read here), and most recently by Yi Lin at the 22nd Congress of the EHA (click here to read more). Immune signature data of cytokine release syndrome and neurologic events from the trial was also presented by Locke during AACR (view here).

Currently, KTE-C19 is being investigated at the phase II/III stage in Mantle Cell Lymphoma (MCL) in the ZUMA-2 trial (NCT02601313) and ZUMA-8 has been planned in Chronic Lymphocytic Leukemia (CLL).

  1. OncLive. EU Approval Sought for Axicabtagene Ciloleucel in Non-Hodgkin Lymphoma. 2017 Jul 31. [Accessed 2017 Aug 01].