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: 10 Sep 2017

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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

  • Registered Acute lymphoblastic leukaemia
  • Phase II Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Multiple myeloma; Non-Hodgkin's lymphoma
  • Phase I B cell lymphoma; B cell prolymphocytic leukaemia; Follicular lymphoma; Mantle-cell lymphoma
  • Preclinical Breast cancer; Mesothelioma; Ovarian cancer; Pancreatic cancer

Most Recent Events

  • 31 Aug 2017 The label for tisagenlecleucel-T contains a black box warning for cytokine release syndrome and neurological toxicities
  • 31 Aug 2017 The US FDA approves the Risk Evaluation and Mitigation Strategy (REMS) for tisagenlecleucel-T
  • 30 Aug 2017 Novartis intends to submit BLA to the US FDA and MAA to the EMA for Diffuse large B-cell lymphoma (In adults, Second line therapy or greater) in 2017
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