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Drugs and Medicinal Substances

Brexucabtagene autoleucel

Antineoplastic and Immunomodulating Agents

Brexucabtagene autoleucel, sold under the brand name Tecartus, is a cell-based gene therapy used to treat mantle cell lymphoma and acute lymphoblastic leukemia. It belongs to the chimeric antigen receptor T cell, or CAR-T, therapy category and was the first cell-based gene therapy approved by the FDA for mantle cell lymphoma. A patient's own T cells are collected and genetically modified to carry a new gene that helps the cells target and destroy lymphoma or leukemia cells, and the engineered cells are then infused back into the patient. It received FDA approval for relapsed or refractory mantle cell lymphoma in July 2020 and European Union approval in December 2020, then FDA approval for relapsed or refractory B-cell precursor acute lymphoblastic leukemia in October 2021 and European Union approval in December 2021.

Facts
Classification
Approval Status
Approved 1
ATC ClassSourced to the subject's own account
L: Antineoplastic and Immunomodulating Agents 2
Route of Administration
Intravenous 3
First Approved / Isolated Year
2020 4
Sources
1. Brexucabtagene autoleucel (Wikipedia)
Lead section, approval-status statement
Quote, Lead section, approval-status statement
Brexucabtagene autoleucel was approved for medical use in the United States in July 2020, and in the European Union in December 2020.
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code L
Quote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
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3. Brexucabtagene autoleucel (Wikipedia)
WikipediaInfobox drug, routes_of_administration
Quote, Infobox drug, routes_of_administration
Intravenous
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4. Drugs.com: Tecartus (brexucabtagene autoleucel) FDA Approval History
FDA Approval History
Quote, FDA Approval History
Tecartus (brexucabtagene autoleucel) FDA approved July 24, 2020 for mantle cell lymphoma
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