Axicabtagene ciloleucel (Yescarta)

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Mechanism of action

From the NCI Drug Dictionary: A preparation of autologous peripheral blood T-lymphocytes (PBTL) that have been transduced with a gammaretroviral vector expressing a chimeric antigen receptor (CAR) consisting of an anti-CD19 single chain variable fragment (scFv) coupled to the costimulatory signaling domain CD28 and the zeta chain of the T-cell receptor (TCR)/CD3 complex (CD3 zeta), with potential immunostimulating and antineoplastic activities. Upon intravenous infusion and re-introduction of axicabtagene ciloleucel into the patient, these cells bind to and induce selective toxicity in CD19-expressing tumor cells.

Toxicity management

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient Drug Information

History of changes in FDA indication

History of changes in EMA indication

History of changes in Health Canada indication

  • 2019-02-13: Initial notice of compliance
  • 2022-09-29: Notice of compliance with conditions for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL) after two or more lines of systemic therapy.

History of changes in PMDA indication

  • 2021-01-22: Initial approval

Also known as

  • Code name: KTE-C19
  • Generic names: Axicel, Axi-cel
  • Brand name: Yescarta