Tisagenlecleucel (Kymriah)

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Mechanism of action

From the NCI Drug Dictionary: Autologous T lymphocytes transduced with a modified lentiviral vector expressing a chimeric antigen receptor (CAR) consisting of an anti-CD19 scFv (single chain variable fragment) and the zeta chain of the TCR/CD3 complex (CD3-zeta), coupled to the signaling domain of 4-1BB (CD137), with potential immunomodulating and antineoplastic activities. Upon transfusion, tisagenlecleucel direct the T lymphocytes to CD19-expressing tumor cells, thereby inducing a selective toxicity in CD19-expressing tumor cells.

Toxicity management

Diseases for which it is established

Diseases for which it is used

Diseases for which it was used

History of changes in FDA indication

History of changes in EMA indication

  • 2017-08-30: Initial marketing authorisation

History of changes in Health Canada indication

  • 2018-09-05: Initial notice of compliance
  • 2022-12-19: Notice of compliance with conditions for adult patients with relapsed or refractory 1, 2, 3a follicular lymphoma (FL) after two or more lines of systemic therapy.

Also known as

  • Code name: CART19, CTL-019
  • Generic name: tisagenlecleucel-T, tisa-cel
  • Brand name: Kymriah