Difference between revisions of "Brexucabtagene autoleucel (Tecartus)"
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==Mechanism of action== | ==Mechanism of action== | ||
From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/brexucabtagene-autoleucel 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. | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/brexucabtagene-autoleucel 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== | ||
| + | *'''[https://www.yescartatecartusrems.com Link to REMS]''' | ||
| + | |||
| + | ==Diseases for which it is established ''(work in progress)''== | ||
| + | *[[B-cell acute lymphoblastic leukemia]] | ||
| + | |||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Mantle cell lymphoma]] | *[[Mantle cell lymphoma]] | ||
==History of changes in FDA indication== | ==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 acute lymphoblastic leukemia|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== | ||
| + | *[https://www.gilead.com/-/media/files/pdfs/medicines/oncology/tecartus/tecartus-pi.pdf Brexucabtagene autoleucel (Tecartus) Package Insert]<ref>[https://www.gilead.com/-/media/files/pdfs/medicines/oncology/tecartus/tecartus-pi.pdf Brexucabtagene autoleucel (Tecartus) Package Insert]</ref> | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' KTE-X19 | *'''Code name:''' KTE-X19 | ||
| + | *'''Generic name:''' brexu-cel | ||
*'''Brand name:''' Tecartus | *'''Brand name:''' Tecartus | ||
| − | [[Category: | + | ==References== |
| + | |||
| + | [[Category:Anti-CD19 CAR T-cells]] | ||
| + | [[Category:Anti-CD3 cellular therapy]] | ||
| + | [[Category:Anti-CD19 cellular therapy]] | ||
| + | [[Category:Anti-CD28 cellular therapy]] | ||
| + | |||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| + | [[Category:B-cell acute lymphoblastic leukemia medications]] | ||
[[Category:Mantle cell lymphoma medications]] | [[Category:Mantle cell lymphoma medications]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:EMA approved in 2020]] | ||
[[Category:REMS program]] | [[Category:REMS program]] | ||
[[Category:Kite Pharma product]] | [[Category:Kite Pharma product]] | ||
Latest revision as of 23:26, 22 September 2023
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
- 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