Axicabtagene ciloleucel - Kite Pharma

Drug Profile

Axicabtagene ciloleucel - Kite Pharma

Alternative Names: Axi-cel; KTE-C19; KTE-C19 CAR; Yescarta

Latest Information Update: 05 Dec 2017

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At a glance

  • Originator Cabaret Biotech
  • Developer Genentech; H. Lee Moffitt Cancer Center and Research Institute; Kite Pharma; National Cancer Institute (USA)
  • Class Antineoplastics; CAR-T cell therapies
  • Mechanism of Action Gene transference; 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; Mantle-cell lymphoma; Acute lymphoblastic leukaemia; Follicular lymphoma
  • New Molecular Entity No

Highest Development Phases

  • Marketed B cell lymphoma; Diffuse large B cell lymphoma
  • Preregistration Follicular lymphoma
  • Phase II Mantle-cell lymphoma
  • Phase I/II Acute lymphoblastic leukaemia; Non-Hodgkin's lymphoma
  • Phase I Leukaemia

Most Recent Events

  • 27 Nov 2017 Launched for B-cell lymphoma (Second-line therapy or greater) in USA (IV)
  • 27 Nov 2017 Launched for Diffuse large B cell lymphoma (Second-line therapy or greater) in USA (IV)
  • 18 Oct 2017 The US FDA approves the Risk Evaluation and Mitigation Strategy (REMS) for axicabtagene ciloleucel
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