Tisagenlecleucel-T - Novartis/University of Pennsylvania

Drug Profile

Tisagenlecleucel-T - Novartis/University of Pennsylvania

Alternative Names: Anti-CD19-CAR retroviral vector-transduced autologous T cells - University of Pennsylvania; Anti-CD19-CAR transduced T cells - Novartis/University of Pennsylvania; CART-019; CART-19; CART-19 cells; Chimeric antigen receptor-modified T cells against CD19 - University of Pennsylvania/Novartis; CTL 019; Kymriah; LG-740; tisagenlecleucel

Latest Information Update: 18 Jan 2018

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At a glance

  • Originator Lentigen Corporation; University of Pennsylvania
  • Developer Beijing Sanwater Biological Technology; Novartis; University of Pennsylvania
  • Class CAR-T cell therapies; Cell therapies; Gene therapies
  • Mechanism of Action CD19 antigen modulators; Gene transference; T lymphocyte replacements; T lymphocyte stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Acute lymphoblastic leukaemia
  • Preregistration Diffuse large B cell lymphoma
  • Phase II Chronic lymphocytic leukaemia; Multiple myeloma; Non-Hodgkin's lymphoma
  • Preclinical Breast cancer; Mesothelioma; Ovarian cancer
  • No development reported B cell lymphoma; B cell prolymphocytic leukaemia; Follicular lymphoma; Mantle-cell lymphoma; Pancreatic cancer

Most Recent Events

  • 17 Jan 2018 The US FDA accepts sBLA for tisagenlecleucel for Diffuse large B-cell lymphoma (In adults, Second-line therapy or greater) for priority review
  • 17 Jan 2018 Tisagenlecleucel receives accelerated assessment status in European Union for Acute lymphoblastic leukaemia (In adolescents, In children, In adults, Second-line therapy or greater) and Diffuse large B-cell lymphoma (In adults, Second-line therapy or greater)
  • 10 Dec 2017 Updated efficacy and safety data from the phase II JULIET trial in Diffuse large B-cell lymphoma released by Novartis
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