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Drugs and Medicinal Substances

Axicabtagene ciloleucel

Antineoplastic and Immunomodulating Agents

Axicabtagene ciloleucel, sold under the brand name Yescarta, is a CAR T cell therapy rather than a conventional chemical drug. A patient's own T cells are collected, genetically engineered outside the body to display a receptor that recognizes the CD19 protein found on certain lymphoma cells, then multiplied and infused back into the same patient to hunt and destroy the cancer. Kite Pharma developed the therapy and the United States Food and Drug Administration first approved it in October 2017 for large B cell lymphoma that had failed standard treatment, covering diffuse large B cell lymphoma, transformed follicular lymphoma and primary mediastinal B cell lymphoma, then expanded the approval in April 2022 to earlier, second line use. It is given as a single intravenous infusion at a certified hospital because of serious risks including cytokine release syndrome and neurological toxicity, and in April 2024 the FDA added a boxed warning after some patients developed secondary T cell cancers.

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
2017 4
Sources
1. Axicabtagene ciloleucel (Wikipedia)
Lead: approval status
Quote, Lead: approval status
Axicabtagene ciloleucel, sold under the brand name Yescarta, is a medication used for the treatment for large B-cell lymphoma that has failed conventional treatment.
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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. Axicabtagene ciloleucel (Wikipedia)
WikipediaInfobox drug, routes_of_administration
Quote, Infobox drug, routes_of_administration
Intravenous injection
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4. Drugs.com: Yescarta (axicabtagene ciloleucel) FDA Approval History
FDA Approval History
Quote, FDA Approval History
Yescarta (axicabtagene ciloleucel) FDA approved October 18, 2017
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