Brexucabtagene autoleucel (Tecartus)

From - A Hematology Oncology Wiki
Jump to navigation Jump to search

Mechanism of action

From the NCI Drug Dictionary: A preparation of autologous peripheral blood T lymphocytes (PBTL) that have been transduced with a retroviral 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 brexucabtagene autoleucel into the patient, these cells bind to and induce selective toxicity in CD19-expressing tumor cells. CD19 antigen is a B-cell-specific cell surface antigen that is expressed in all B-cell lineage malignancies. CD3 zeta is one of several membrane-bound polypeptides found in the TCR/CD3 complex; it regulates both the assembly and cell surface expression of TCR complexes. CD28 is essential for CD4+ T-cell proliferation, interleukin-2 production, and T-helper type-2 (Th2) development. Brexucabtagene autoleucel has the same construct as axicabtagene ciloleucel, but differs in the manufacturing process in that brexucabtagene autoleucel includes specific T-cell selection and lymphocyte enrichment necessary for activity against certain B-cell malignancies.

Toxicity management

Diseases for which it is established (work in progress)

Diseases for which it is used

History of changes in FDA indication

History of changes in EMA indication

  • 2020-12-14: Initial conditional authorization.

Patient Drug Information

Also known as

  • Code name: KTE-X19
  • Generic name: brexu-cel
  • Brand name: Tecartus