Axicabtagene ciloleucel
| Clinical data | |
|---|---|
| Trade names | Yescarta |
| AHFS/Drugs.com | yescarta |
| Routes of administration | Intravenous injection |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| DrugBank | |
Axicabtagene ciloleucel (KTE-C19, Axi-cel), marketed as 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]
The T-cells are engineered to target CD19 receptors on the cancerous B cells.[3] The cost for treatment is 373,000 USD in the United States.[4]
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.[3]
History
It was developed by California-based Kite Pharma.
Axi-cel was awarded US FDA breakthrough therapy designation on October 18, 2017 for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.[5] 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.[6]
The FDA granted approval on October 18, 2017 for the second-line treatment of diffuse large B-cell lymphoma.[3][7]
References
- ^ "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 Oct 2023.
- ^ [https://secure.medicalletter.org/TML-article-1551f Axicabtagene Ciloleucel (Yescarta) for B-Cell Lymphoma] 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". FDA. Retrieved 20 October 2017.
- ^ "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". www.gilead.com. 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 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) Mar 2017
- ^ F.D.A. Approves Second Gene-Altering Treatment for Cancer 2017
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