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KTE-X19 marketing authorization application fully validated by the EMA

Feb 4, 2020

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. 3KTE-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.

  1. European Pharmaceutical Review online. EC approves KTE-X19 for treatment of mantle cell lymphoma. https://www.europeanpharmaceuticalreview.com/news/111715/ec-approves-kte-x19-for-treatment-of-mantle-cell-lymphoma/.Published; January 30 2020, [Accessed 31 January 2020]
  2. BusinessWire online. European Medicines Agency Validates Kite’s Marketing Application for Company’s Second CAR T Cell Therapy. https://www.businesswire.com/news/home/20200128005723/en/European-Medicines-Agency-Validates-Kite%E2%80%99s-Marketing-Application. Published; January 28 2020, [Accessed 31 January 2020]
  3. Shah B, Bishop M, Oluwole O, Logan A, Baer M, Donnellan W, OʼDwyer K, Holmes H, Arellano M, Ghobadi A, Pagel J, Lin Y, Cassaday R, Park J, Mardiros A, Shen T, Goyal L, Vezan R, Jain R, Wierda W. KTE-X19, an anti-CD19 chimeric antigen receptor T cell therapy, in adult patients with relapsed/refractory acute lymphoblastic leukemia: end of phase 1 results of ZUMA-3. Poster presented at: EHA24 2019 annual conference; June 15, 2019; Amsterdam