Axicabtagene ciloleucel


Axicabtagene ciloleucel, sold under the brand name Yescarta, is a treatment for large B-cell lymphoma that has failed conventional treatment. 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. Axicabtagene treatment carries a risk for cytokine release syndrome and neurological toxicities.
The T-cells are engineered to target CD19 receptors on the cancerous B cells. The cost for treatment is US$373,000 in the United States.

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 prior to treatment of any patients.

History

It was developed by California-based Kite Pharma.
Axicabtagene ciloleucel was awarded U.S. Food and Drug Administration breakthrough therapy designation on 18 October 2017, for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma. It also received priority review and orphan drug designation.
Based on the ZUMA-1 trial, Kite submitted a biologics license application for axicabtagene in March 2017, for the treatment of non-Hodgkin lymphoma.
The FDA granted approval on 18 October 2017, for the second-line treatment of diffuse large B-cell lymphoma.