Axicabtagene ciloleucel

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]

Axicabtagene ciloleucel
Clinical data
Trade namesYescarta
AHFS/Drugs.comProfessional Drug Facts
MedlinePlusa618003
License data
Routes of
administration		Intravenous injection
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank
KEGG

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

Side effects

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 prior to treatment of any patients.[2]

History

It was developed by California-based Kite Pharma.

Axi-cel was awarded US FDA breakthrough therapy designation on 18 October 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 18 October 2017, for the second-line treatment of diffuse large B-cell lymphoma.[2][6]

References
  1. Axicabtagene Ciloleucel (Yescarta) for B-Cell Lymphoma Med Lett Drugs Ther. 2018 Jul 16;60(1551):e122-123
  2. "FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma". FDA (Press release). Retrieved 20 October 2017.
  3. "Kite's Yescarta (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy". www.gilead.com. Retrieved 20 October 2017.
  4. "Kite to Present Two Plenary Presentations from the ZUMA-1 Pivotal Trial of Axicabtagene Ciloleucel at the 2017 American Association of Cancer Research Annual Meeting". Archived from the original on 21 June 2017. Retrieved 9 May 2017.
  5. "Kite Completes Submission of U.S. Biologics License Application (BLA) for Axicabtagene Ciloleucel as the First CAR-T Therapy for the Treatment of Patients With Aggressive Non-Hodgkin Lymphoma (NHL) Mar 2017". Archived from the original on 25 April 2017. Retrieved 9 May 2017.
  6. F.D.A. Approves Second Gene-Altering Treatment for Cancer 2017
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