Axicabtagene ciloleucel

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Axicabtagene ciloleucel
Clinical data
Trade names Yescarta
AHFS/Drugs.com yescarta
Routes of
administration
Intravenous injection
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank

Axicabtagene ciloleucel (KTE-C19, Axi-cel), marketed as Yescarta, is a treatment for large B-cell lymphoma that has failed conventional treatment[1]. T cells are removed from a person with lymphoma and genetically engineered to produce a specific T-cell receptor. The resulting chimeric antigen receptor T cells or "CAR-Ts" that react to the cancer are then given back to the person to populate the bone marrow.[2] Axicabtagene treatment carries a risk for cytokine release syndrome (CRS) and neurological toxicities.[2]

The T-cells are engineered to target CD19 receptors on the cancerous B cells.[2] The cost for treatment is 373,000 USD in the United States.[3]

Side effects[edit]

Because treatment with axicabtagene carries a risk of cytokine release syndrome and neurological toxicities, the FDA has mandated that hospitals be certified for its use.[2]

History[edit]

It was developed by California-based Kite Pharma.

Axi-cel was awarded US FDA breakthrough therapy designation on October 18, 2017 for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.[4] It also received priority review and Orphan drug designation.[2]

Based on the ZUMA-1 trial, Kite submitted a biologics license application for axicabtagene in March 2017 for the treatment of Non-Hodgkin lymphoma.[5]

The FDA granted approval on October 18, 2017 for the second-line treatment of diffuse large B-cell lymphoma.[2][6]

References[edit]