Axicabtagene ciloleucel

Axicabtagene ciloleucel, sold under the brand name Yescarta, is a treatment for large B-cell lymphoma that has failed conventional treatment.[2] 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.[3] Axicabtagene treatment carries a risk for cytokine release syndrome (CRS) and neurological toxicities.[3]

Axicabtagene ciloleucel
Clinical data
Trade namesYescarta
Other namesKTE-C19, Axi-cel
AHFS/Drugs.comProfessional Drug Facts
MedlinePlusa618003
License data
Pregnancy
category
Routes of
administration		Intravenous injection
ATC code
Legal status
Legal status
Identifiers
DrugBank
UNII
KEGG

Due to CD19 is a pan-B cell marker,[4] the T-cells that are engineered to target CD19 receptors on the cancerous B cells[3] also influence normal B cells, except some plasma cells.[5]

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.[3]

History

It was developed by California-based Kite Pharma.[6]

Axicabtagene ciloleucel was awarded U.S. Food and Drug Administration (FDA) breakthrough therapy designation on 18 October 2017, for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.[7] It also received priority review and orphan drug designation.[3]

Based on the ZUMA-1 trial, Kite submitted a biologics license application for axicabtagene in March 2017, for the treatment of non-Hodgkin lymphoma.[8]

The FDA granted approval on 18 October 2017, for the second-line treatment of diffuse large B-cell lymphoma.[3][9][10]

References
  1. "T Cells - Axicabtagene ciloleucel, cryopreserved - T - Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion". Therapeutic Goods Administration (TGA). Retrieved 16 September 2020.
  2. Axicabtagene Ciloleucel (Yescarta) for B-Cell Lymphoma Med Lett Drugs Ther. 2018 Jul 16;60(1551):e122-123
  3. "FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma". U.S. Food and Drug Administration (Press release). Retrieved 20 October 2017. This article incorporates text from this source, which is in the public domain.
  4. Wang K, Wei G, Liu D (November 2012). "CD19: a biomarker for B cell development, lymphoma diagnosis and therapy". Experimental Hematology & Oncology. 1 (1): 36. doi:10.1186/2162-3619-1-36. PMID 23210908.
  5. Halliley JL, Tipton CM, Liesveld J, Rosenberg AF, Darce J, Gregoretti IV, et al. (July 2015). "Long-Lived Plasma Cells Are Contained within the CD19(-)CD38(hi)CD138(+) Subset in Human Bone Marrow". Immunity. 43 (1): 132–45. doi:10.1016/j.immuni.2015.06.016. PMID 26187412.
  6. "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". Gilead (Press release). Retrieved 20 October 2017.
  7. "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.
  8. "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) March 2017". Archived from the original on 25 April 2017. Retrieved 9 May 2017.
  9. F.D.A. Approves Second Gene-Altering Treatment for Cancer 2017
  10. "Yescarta (axicabtagene ciloleucel)". U.S. Food and Drug Administration (FDA). 18 October 2017. Retrieved 1 April 2020.
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