Axicabtagene ciloleucel

Drug Profile

Axicabtagene ciloleucel

Alternative Names: KTE-C19; KTE-C19 CAR

Latest Information Update: 16 Jun 2017

Price : $50

At a glance

  • Originator Cabaret Biotech
  • Developer Genentech; Kite Pharma; National Cancer Institute (USA)
  • Class Antineoplastics; CAR-T cell therapies
  • Mechanism of Action CD19 antigen modulators; Gene transference; T lymphocyte replacements; T-cell receptor antigen modulators
  • 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; Acute lymphoblastic leukaemia; Follicular lymphoma; Mantle-cell lymphoma
  • New Molecular Entity No

Highest Development Phases

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

Most Recent Events

  • 06 Jun 2017 Planned Prescription Drug User Fee Act (PDUFA) date for Non-Hodgkin's lymphoma (Second-line therapy or greater) in USA (IV) is 2017-11-29
  • 05 Jun 2017 Adverse events data from the phase I/II ZUMA-3 trial in Acute lymphoblastic leukaemia released by Kite Pharma
  • 26 May 2017 Axicabtagene ciloleucel receives priority review status for Non hodgkin's lymphoma (Second line therapy or greater) in USA
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