Axicabtagene ciloleucel

Source: Wikipedia, the free encyclopedia.

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

Axicabtagene ciloleucel, sold under the brand name Yescarta, is a

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

plasma cells.[11]

Adverse 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.[9]

In April 2024, the FDA label boxed warning was expanded to include T cell malignancies.[12]

History

It was developed by California-based Kite Pharma.[13]

Axicabtagene ciloleucel was awarded U.S.

orphan drug designation.[9]

Based on the ZUMA-1 trial, Kite submitted a biologics license application for axicabtagene in March 2017, for the treatment of non-Hodgkin lymphoma.[15]

The FDA granted approval in October 2017, for the

second-line treatment of diffuse large B-cell lymphoma.[9][16][6]

In April 2022, the FDA approved axicabtagene ciloleucel for adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within twelve months of first-line chemoimmunotherapy.[17] It is not indicated for the treatment of patients with primary central nervous system lymphoma.[17]

Approval was based on ZUMA-7, a randomized, open-label, multicenter trial in adults with primary refractory LBCL or relapse within twelve months following completion of first-line therapy.[17] Participants had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous hematopoietic stem cell transplantation (HSCT).[17] A total of 359 participants were randomized 1:1 to receive a single infusion of axicabtagene ciloleucel following fludarabine and cyclophosphamide lymphodepleting chemotherapy or to receive second-line standard therapy, consisting of two or three cycles of chemoimmunotherapy followed by high-dose therapy and autologous HSCT in participants who attained complete remission or partial remission.[17] In the ZUMA-7 trial, patients treated with axicabtagene ciloleucel had superior clinical outcomes compared with the previous standard of care, including improved overall survival with an estimated 4-year overall survival rate of 54.6% for axicabtagene ciloleucel, compared with 46% for the previous standard of care.[18]

In January 2023, the National Institute for Health and Care Excellence (NICE) recommended axicabtagene ciloleucel to treat adult patients with diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B-cell lymphoma (PMBCL) who have already been treated with two or more systemic therapies.[19][20]

Society and culture

Names

Axicabtagene ciloleucel is the international nonproprietary name.[21]

References

  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
    . 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. ^ a b "Yescarta (axicabtagene ciloleucel)". U.S. Food and Drug Administration (FDA). 18 October 2017. Archived from the original on 7 August 2020. Retrieved 1 April 2020.
  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 d e f "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. PMID 23210908
    .
  11. PMID 26187412
    .
  12. ^ "FDA Requires Boxed Warning for T cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies". U.S. Food and Drug Administration (FDA). 18 April 2024. Archived from the original on 19 April 2024. Retrieved 19 April 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  13. ^ "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). Archived from the original on 1 August 2019. Retrieved 20 October 2017.
  14. ^ "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.
  15. ^ "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.
  16. ^ "F.D.A. Approves Second Gene-Altering Treatment for Cancer 2017". Archived from the original on 19 October 2017. Retrieved 19 October 2017.
  17. ^ a b c d e "FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma". U.S. Food and Drug Administration (FDA). 1 April 2022. Archived from the original on 3 April 2022. Retrieved 4 April 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  18. S2CID 259074779
    .
  19. ^ Kansteiner F (26 January 2023). "After years of back-and-forth, Gilead's CAR-T Yescarta sways England's cost watchdog NICE". Fierce Pharma. Archived from the original on 31 January 2023. Retrieved 31 January 2023.
  20. ^ biopharma-reporter.com (26 January 2023). "Gilead's Yescarta set to become England's first routinely available personalized immunotherapy for lymphoma". biopharma-reporter.com. Archived from the original on 28 January 2023. Retrieved 31 January 2023.
  21. hdl:10665/330941
    .

External links
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