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Axicabtagene ciloleucel information


Axicabtagene ciloleucel
Clinical data
Trade namesYescarta
Other namesKTE-C19, Axi-cel
AHFS/Drugs.comProfessional Drug Facts
MedlinePlusa618003
License data
  • US DailyMed: Axicabtagene_ciloleucel
Pregnancy
category
  • AU: C[1][2]
Routes of
administration
Intravenous injection
ATC code
  • L01XL03 (WHO)
Legal status
Legal status
  • AU: Class 4 biological[1]
  • CA: ℞-only / Schedule D[4]
  • UK: POM (Prescription only)
  • US: WARNING[3]Rx-only[5][6]
  • EU: Rx-only[7]
Identifiers
DrugBank
  • DB13915
UNII
  • U2I8T43Y7R
KEGG
  • D11144

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.[8] 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 (CAR-Ts) that react to the cancer are then given back to the person to populate the bone marrow.[9] Axicabtagene treatment carries a risk for cytokine release syndrome (CRS) and neurological toxicities.[9]

Due to CD19 being a pan-B cell marker,[10] the T-cells that are engineered to target CD19 receptors on the cancerous B cells[9] also influence normal B cells, except some plasma cells.[11]

  1. ^ a b "T Cells - Axicabtagene ciloleucel, cryopreserved - T - Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion". Therapeutic Goods Administration (TGA). Archived from the original on 5 December 2023. Retrieved 16 September 2020.
  2. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
  3. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  4. ^ "Summary Basis of Decision (SBD) for Yescarta". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.
  5. ^ "Yescarta- axicabtagene ciloleucel suspension". DailyMed. 31 January 2022. Archived from the original on 5 March 2022. Retrieved 4 April 2022.
  6. ^ Cite error: The named reference FDA Yescarta was invoked but never defined (see the help page).
  7. ^ "Yescarta EPAR". European Medicines Agency. 16 December 2014. Archived from the original on 28 December 2023. Retrieved 27 February 2024.
  8. ^ Axicabtagene Ciloleucel (Yescarta) for B-Cell Lymphoma Archived 29 November 2022 at the Wayback Machine Med Lett Drugs Ther. 2018 Jul 16;60(1551):e122-123
  9. ^ a b c "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). Archived from the original on 5 March 2022. Retrieved 20 October 2017. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ 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. PMC 3520838. PMID 23210908.
  11. ^ 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. PMC 4680845. PMID 26187412.

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