Axicabtagene ciloleucel
Axicabtagene ciloleucel
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Axicabtagene ciloleucel

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Axicabtagene ciloleucel

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. 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. Axicabtagene treatment carries a risk for cytokine release syndrome (CRS) and neurological toxicities.

Due to CD19 being a pan-B cell marker, the T-cells that are engineered to target CD19 receptors on the cancerous B cells also influence normal B cells, except some plasma cells.

Because treatment with axicabtagene carries a risk of cytokine release syndrome and neurological toxicities, the Food and Drug Administration (FDA) has mandated that hospitals be certified for its use prior to treatment of any patients.

In April 2024, the FDA label boxed warning was expanded to include T cell malignancies.

It was developed by California-based Kite Pharma.

Axicabtagene ciloleucel was awarded U.S. FDA breakthrough therapy designation in 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 in October 2017, for the second-line treatment of diffuse large B-cell lymphoma.

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