Brand name: Tecartus
Use in Cancer Treatment
Adults with: Brexucabtagene autoleucel is used to treat relapsed (refractory) or relapsed (come back) mantle cell lymphoma (does not respond to treatment). The FDA’s Accelerated Approval Program has authorised it. Confirmatory trials must prove that brexucabtagene autoleucel offers a therapeutic benefit in these individuals as a condition of licensure.
Brexucabtagene autoleucel is exclusively accessible as part of the Tecartus REMS programme (Risk Evaluation and Mitigation Strategies Exit Disclaimer).
Brexucabtagene autoleucel is also under research for use in the treatment of various cancers.
A preparation of autologous peripheral blood T lymphocytes (PBTL) 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 signalling domain CD28 and the zeta chain of the T-cell receptor (TCR)/CD3 complex (CD3 zeta) with potential immunostimulatory and antineoplastitic properties Brexucabtagene autoleucel cells attach to and cause selective toxicity in CD19-expressing tumor cells after intravenous injection and reintroduction into the patient. All B-cell lineage cancers express CD19 antigen, which is a B-cell-specific cell surface antigen.
The membrane-bound polypeptide CD3 zeta is one of numerous membrane-bound polypeptides in the TCR/CD3 complex; and it also controls TCR complex formation and cell surface expression. CD28 is essential for CD4+ T-cell proliferation, interleukin-2 production, and the development of T-helper type-2 (Th2). Brexucabtagene autoleucel has the same structure as axicabtagene ciloleucel, but the manufacturing method varies in that it contains particular T-cell selection and lymphocyte enrichment, which is a requirement for action against certain B-cell malignancies.
MedlinePlus Information– A summary of key facts regarding this medication in layman’s terms, which may contain the following:
Cautions about this medicine; what it’s used for and how it’s used; what you should tell your doctor before taking it, what you should know about it before using it, other drugs that might interact with it, and possible negative effects.
Experts frequently investigate drugs to see whether they can assist, treat or prevent conditions other than those for which have an authorization. This patient information leaflet only covers medications with an authorization. Much of the material, though, might also apply to the authorization of uses which are also under investigation.