Idecabtagene vicleucel, sold under the brand name Abecma, is a cell-based gene therapy used to treat multiple myeloma. It is a B-cell maturation antigen directed chimeric antigen receptor T-cell therapy, made by genetically modifying a patient's own T-cells so they recognize and attack myeloma cells that carry the BCMA protein. It is indicated for adults with relapsed or refractory multiple myeloma who have already received at least two prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. The United States Food and Drug Administration approved it in March 2021, its first approval of a cell-based gene therapy for multiple myeloma, and the European Union approved it in August 2021. It is developed by Celgene Corporation, a Bristol-Myers Squibb company.
Facts
Classification
Approval Status ATC ClassSourced to the subject's own accountL: Antineoplastic and Immunomodulating Agents 2 Route of Administration First Approved / Isolated Year Connections
Sources
1. Idecabtagene vicleucel (Wikipedia)
Lead section, approval-status statementQuote, Lead section, approval-status statement
Idecabtagene vicleucel was approved for medical use in the United States in March 2021.
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. Idecabtagene vicleucel (Wikipedia)
WikipediaInfobox drug, routes_of_administrationQuote, Infobox drug, routes_of_administration
Intravenous
View the Source 4. Drugs.com: Abecma (idecabtagene vicleucel) FDA Approval History
FDA Approval HistoryQuote, FDA Approval History
Abecma (idecabtagene vicleucel) FDA approved March 26, 2021
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