Tisagenlecleucel-T

Drug Profile

Tisagenlecleucel-T

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; LG-740

Latest Information Update: 10 Mar 2017

Price : $50

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II Acute lymphoblastic leukaemia; 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

  • 02 Mar 2017 Novartis initiates enrolment in a phase II trial for Acute lymphoblastic leukaemia (Second-line therapy or greater) in Austria (EudraCT2016-001991-31)
  • 13 Feb 2017 University of Pennsylvania terminates a phase II trial prior to enrolment for Acute lymphoblastic leukaemia (Second-line therapy or greater) in USA (NCT02167360)
  • 06 Dec 2016 Novartis plans to file an application with the European Medicines Agency in the EU for Acute lymphoblastic leukaemia in 2017
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