Brexucabtagene autoleucel (Tecartus)
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.
Diseases for which it is established (work in progress)
Diseases for which it is used
History of changes in FDA indication
- 2020-07-24: Granted accelerated approval for the treatment of adult patients with relapsed/refractory mantle cell lymphoma. (Based on ZUMA-2)
- 2021-10-01: Approved for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). (Based on ZUMA-3)
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