Medication to treat large B-cell lymphoma
Pharmaceutical compound
Axicabtagene ciloleucel , sold under the brand nameYescarta , is amedication used for the treatment forlarge B-cell lymphoma that has failed conventional treatment.[ 7] T cells are removed from a person with lymphoma andgenetically engineered to produce a specificT-cell receptor . The resultingchimeric antigen receptor T cells (CAR-Ts) that react to the cancer are then given back to the person to populate the bone marrow.[ 8] cytokine release syndrome (CRS) and neurological toxicities.[ 8]
Due toCD19 being a pan-B cell marker,[ 9] CD19 receptors on the cancerousB cells [ 8] B cells , except someplasma cells .[ 10]
Because treatment with axicabtagene carries a risk ofcytokine release syndrome and neurological toxicities, theFood and Drug Administration (FDA) has mandated that hospitals be certified for its use prior to treatment of any patients.[ 8]
In April 2024, the FDA labelboxed warning was expanded to include T cell malignancies.[ 11]
It was developed by California-basedKite Pharma .[ 12]
Axicabtagene ciloleucel was awarded U.S. FDAbreakthrough therapy designation in October 2017, fordiffuse large B-cell lymphoma ,transformed follicular lymphoma , andprimary mediastinal B-cell lymphoma .[ 13] [ 14] priority review andorphan drug designation .[ 8]
Based on the ZUMA-1 trial, Kite submitted abiologics license application for axicabtagene in March 2017, for the treatment ofnon-Hodgkin lymphoma .[ 15] [ 16]
The FDA granted approval in October 2017, for thesecond-line treatment of diffuse large B-cell lymphoma.[ 8] [ 17] [ 5]
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.[ 18] [ 18]
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.[ 18] [ 18] [ 18] [ 19]
In January 2023, theNational Institute for Health and Care Excellence (NICE) recommended axicabtagene ciloleucel to treat adult patients withdiffuse large B-cell lymphoma (DLBCL) orprimary mediastinal large B-cell lymphoma (PMBCL) who have already been treated with two or more systemic therapies.[ 20] [ 21]
Society and culture [ edit ] Axicabtagene ciloleucel is theinternational nonproprietary name .[ 22]
^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. Retrieved16 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. Retrieved13 May 2022 .^ "Summary Basis of Decision (SBD) for Yescarta" .Health Canada Archived from the original on 31 May 2022. Retrieved29 May 2022 .^ "Yescarta- axicabtagene ciloleucel suspension" .DailyMed . 31 January 2022.Archived from the original on 5 March 2022. Retrieved4 April 2022 .^a b "Yescarta (axicabtagene ciloleucel)" .U.S.Food and Drug Administration (FDA) . 18 October 2017. Archived fromthe original on 7 August 2020. Retrieved1 April 2020 .^ "Yescarta EPAR" .European Medicines Agency . 16 December 2014.Archived from the original on 28 December 2023. Retrieved27 February 2024 .^ Axicabtagene Ciloleucel (Yescarta) for B-Cell Lymphoma Archived 29 November 2022 at theWayback 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 fromthe original on 5 March 2022. Retrieved20 October 2017 .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 fromthe original on 19 April 2024. Retrieved19 April 2024 .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. Retrieved20 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 fromthe original on 21 June 2017. Retrieved9 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. Retrieved1 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 fromthe original on 25 April 2017. Retrieved9 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 fromthe original on 6 December 2022. Retrieved1 July 2024 – via Business Wire.^ "F.D.A. Approves Second Gene-Altering Treatment for Cancer" .The New York Times Archived from the original on 19 October 2017. Retrieved19 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 fromthe original on 3 April 2022. Retrieved4 April 2022 .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. Retrieved31 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. Retrieved31 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
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