Axicabtagene ciloleucel

Axicabtagene ciloleucel
Clinical data
Trade names	Yescarta
Other names	KTE-C19, Axi-cel
AHFS/Drugs.com	Monograph
MedlinePlus	a618003
License data	US DailyMed: Axicabtagene_ciloleucel;
Pregnancy; category	AU: C; ;
Routes of; administration	Intravenous injection
ATC code	L01XL03 (WHO) ;
Legal status
Legal status	AU: Class 4 biological; CA: ℞-only / Schedule D; UK: POM (Prescription only); US: WARNINGRx-only; EU: Rx-only;
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]

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. Food and Drug Administration (FDA) breakthrough therapy designation in October 2017, for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.^[14]^[15] It also received priority review and 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.^[16]^[17]

The FDA granted approval in October 2017, for the second-line treatment of diffuse large B-cell lymphoma.^[9]^[18]^[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.^[19] It is not indicated for the treatment of patients with primary central nervous system lymphoma.^[19]

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.^[19] Participants had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous hematopoietic stem cell transplantation (HSCT).^[19] 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.^[19] 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.^[20]

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.^[21]^[22]

Society and culture

Names

Axicabtagene ciloleucel is the international nonproprietary name.^[23]

References

^ ^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.
^ "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.
^ "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.
^ "Summary Basis of Decision (SBD) for Yescarta". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.
^ "Yescarta- axicabtagene ciloleucel suspension". DailyMed. 31 January 2022. Archived from the original on 5 March 2022. Retrieved 4 April 2022.
^ ^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.
^ "Yescarta EPAR". European Medicines Agency. 16 December 2014. Archived from the original on 28 December 2023. Retrieved 27 February 2024.
^ 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
^ ^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. This article incorporates text from this source, which is in the public domain.
^ 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.
^ 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.
^ "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. This article incorporates text from this source, which is in the public domain.
^ "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.
^ "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". Kite Pharma (Press release). 30 March 2017. Archived from the original on 21 June 2017. Retrieved 9 May 2017.
^ "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" (Press release). Kite Pharma. 30 March 2017. Archived from the original on 1 July 2024. Retrieved 1 July 2024 – via Business Wire.
^ "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)". Kite Pharma (Press release). 31 March 2017. Archived from the original on 25 April 2017. Retrieved 9 May 2017.
^ "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)" (Press release). Kite Pharma. 31 March 2017. Archived from the original on 6 December 2022. Retrieved 1 July 2024 – via Business Wire.
^ "F.D.A. Approves Second Gene-Altering Treatment for Cancer". The New York Times. 18 October 2017. Archived from the original on 19 October 2017. Retrieved 19 October 2017.
^ ^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. This article incorporates text from this source, which is in the public domain.
^ Westin J, Oluwole OO (July 2023). "Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma". New England Journal of Medicine. 2023 (389): 148–157. doi:10.1056/NEJMoa2301665. hdl:11585/961908. PMID 37272527. S2CID 259074779.
^ 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.
^ 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.
^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.

External links

"Axicabtagene Ciloleucel". National Cancer Institute. 20 October 2017.
"Axicabtagene Ciloleucel". NCI Drug Dictionary. National Cancer Institute.

[AU_Yescarta_PI-1] "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.

[FDA-AllBoxedWarnings-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.

[Yescarta_FDA_label-5] "Yescarta- axicabtagene ciloleucel suspension". DailyMed. 31 January 2022. Archived from the original on 5 March 2022. Retrieved 4 April 2022.

[FDA_Yescarta-6] "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.

[Yescarta_EPAR-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

[FDAapprove-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. 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.

[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. 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". Kite Pharma (Press release). 30 March 2017. Archived from the original on 21 June 2017. Retrieved 9 May 2017.

[15] "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" (Press release). Kite Pharma. 30 March 2017. Archived from the original on 1 July 2024. Retrieved 1 July 2024 – via Business Wire.

[16] "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)". Kite Pharma (Press release). 31 March 2017. Archived from the original on 25 April 2017. Retrieved 9 May 2017.

[17] "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)" (Press release). Kite Pharma. 31 March 2017. Archived from the original on 6 December 2022. Retrieved 1 July 2024 – via Business Wire.

[18] "F.D.A. Approves Second Gene-Altering Treatment for Cancer". The New York Times. 18 October 2017. Archived from the original on 19 October 2017. Retrieved 19 October 2017.

[FDA_20220401-19] "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. This article incorporates text from this source, which is in the public domain.

[pmid37272527-20] Westin J, Oluwole OO (July 2023). "Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma". New England Journal of Medicine. 2023 (389): 148–157. doi:10.1056/NEJMoa2301665. hdl:11585/961908. PMID 37272527. S2CID 259074779.

[21] 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.

[22] rma-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.

[23] World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.

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Axicabtagene ciloleucel

Adverse effects

History

Society and culture

Names

References

External links

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