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Axicabtagene ciloleucel - Kite Pharma

Drug Profile

Axicabtagene ciloleucel - Kite Pharma

Alternative Names: Anti-CD19-CAR-lentiviral-vector-transduced-autologous-T-cells-Kite-Pharma; Anti-CD19-CAR-PBL-Kite-Pharma/NCI; Anti-CD19-CAR-T-cell-therapy-Kite-Pharma/NCI; Anti-CD19-CAR-transduced-T-cells-Kite-Pharma/NCI; Anti-CD19-chimeric-antigen-receptor-lentiviral-vector-transduced-autologous-T-cells-Kite-Pharma; Anti-CD19-chimeric-antigen-receptor-peripheral-blood-lymphocytes-Kite-Pharma; Anti-CD19-chimeric-antigen-receptor-T-cells-Kite-Pharma/NCI; Anti-CD19-chimeric-antigen-receptor-transduced-T-cells-Kite-Pharma/NCI; anti-human CD19 CAR-T cell injection; Axi-cel®; FKC-876; KTE-C19; KTE-C19 CAR; YESCARTA; Yescarta; Yescarta®

Latest Information Update: 10 Nov 2020

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At a glance

  • Originator Cabaret Biotech
  • Developer Daiichi Sankyo Inc; Genentech; H. Lee Moffitt Cancer Center and Research Institute; Kite Pharma; Kite Pharma - Fosun Pharma (JV); National Cancer Institute (USA)
  • Class Antineoplastics; CAR-T cell therapies; Gene therapies; Immunotherapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Diffuse large B cell lymphoma; Chronic lymphocytic leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma; Mantle-cell lymphoma; Follicular lymphoma; B-cell lymphoma
  • New Molecular Entity No

Highest Development Phases

  • Marketed B-cell lymphoma; Diffuse large B cell lymphoma
  • Preregistration Follicular lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma
  • Preclinical Leukaemia

Most Recent Events

  • 05 Nov 2020 Axicabtagene ciloleucel receives priority review status for Follicular lymphoma (Second-line therapy or greater) in USA
  • 05 Nov 2020 FDA assigns PDUFA action date of 05/03/2021 for Axicabtagene ciloleucel for Follicular lymphoma
  • 05 Oct 2020 Phase-II clinical trials in Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater) in USA (IV) (NCT04150913)
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