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 ATC ClassSourced to the subject's own accountL: Antineoplastic and Immunomodulating Agents 2 Route of Administration First Approved / Isolated Year Sources
1. Brexucabtagene autoleucel (Wikipedia)
Lead section, approval-status statementQuote, 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.
View the Source 2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code LQuote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
View the Source 3. Brexucabtagene autoleucel (Wikipedia)
WikipediaInfobox drug, routes_of_administrationQuote, Infobox drug, routes_of_administration
Intravenous
View the Source 4. Drugs.com: Tecartus (brexucabtagene autoleucel) FDA Approval History
FDA Approval HistoryQuote, FDA Approval History
Tecartus (brexucabtagene autoleucel) FDA approved July 24, 2020 for mantle cell lymphoma
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