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Lisocabtagene maraleucel - Juno Therapeutics

Drug Profile

Lisocabtagene maraleucel - Juno Therapeutics

Alternative Names: anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy - Juno Therapeutics; anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy - Juno Therapeutics; EGFRt-4-1BB-modified-CAR-CD8+-and-CD4+-T-lymphocytes-Juno-Therapeutics; Gene modified autologous T cells; JCAR 017; Liso-cel

Latest Information Update: 19 Feb 2020

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At a glance

  • Originator Juno Therapeutics
  • Developer Celgene Corporation; Juno Therapeutics; Seattle Children's Hospital
  • Class 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
  • New Molecular Entity No

Highest Development Phases

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

Most Recent Events

  • 13 Feb 2020 FDA assigns PDUFA action date of 17/08/2020 for Lisocabtagene Maraleucel for relapsed or refractory large B-cell lymphoma after at least two prior therapies
  • 13 Feb 2020 The US FDA accepts BLA for lisocabtagene maraleucel for priority review
  • 29 Jan 2020 Celgene plans a phase II TRANSCEND FL trial in Non-Hodgkin's lymphoma (Second-line therapy of greater) (IV, Infusion) in April 2020 (NCT04245839)
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