DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
| Yescarta is the second gene therapy product approval in the U.S. |
The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). Continue reading.
Axicabtagene ciloleucel is a chimeric antigen receptor (CAR) T cell therapy for the treatment of Diffuse large B-cell lymphoma (DLBCL), which is a type of a non-Hodgkin lymphoma (NHL). It is the second cell-based gene therapy that is FDA-approved but the first in the treatment of large B-cell lymphoma in adult patients. Uniquely, axicabtagene ciloleucel utilizes each patient’s own immune system where each dose of the drug consists of the patient’s genetically modified T-cells that were previously collected. The modified version of the T-cell expresses a new gene that targets and kills the lymphoma cells and is infused back into the patient.
Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL in adults that mostly originates from the lymph nodes but can initiate outside of the lymphatic system. Lymphoma cells appear to be much larger in size than normal lymphocytes. In a multicenter clinical trial, the patients who were treated with axicabtagene ciloleucel achieved the complete remission rate of 51%.
Developed by Kite Pharma, Inc., it was approved on October 18th, 2017 by the FDA as an intravenously infused anticancer therapy and is marketed under the brand name Yescarta
Axicabtagene ciloleucel (KTE-C19, Axi-cel), marketed as Yescarta, is an adoptive cell transfer therapy for used for certain cases of large B-cell lymphoma. In this treatment T cells from a person with cancer are removed, genetically engineered to make a specific T-cell receptor (a chimeric T cell receptor, or “CAR-T“) that reacts to the cancer, and are given back to the person.[1] Axicabtagene carries a risk for cytokine release syndrome (CRS) and neurological toxicities.[1]
The person’s T-cells are engineered to target CD19.[1] The CD19 are found on the surface of certain cancerous cells.[1] The cost for treatment is 373,000 USD in the United States.[2]
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.[1]
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.[3] It also received priority review and Orphan drug designation.[1]
Based on the ZUMA-1 trial, Kite submitted a biologics license application for axicabtagene in March 2017 for the treatment of Non-Hodgkin lymphoma.[4]
The FDA granted approval on October 18 for the second-line treatment of diffuse large B-cell lymphoma.[5][1]
References
- ^ Jump up to:a b c d e f g “FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma”. FDA. Retrieved 20 October 2017.
- Jump up^ “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”. http://www.gilead.com. Retrieved 20 October 2017.
- Jump up^ 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
- Jump up^ 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
- Jump up^ F.D.A. Approves Second Gene-Altering Treatment for Cancer 2017
| Clinical data | |
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| Trade names | Yescarta |
| AHFS/Drugs.com | yescarta |
| Routes of administration |
Intravenous injection |
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New Drug Approvals 