Axicabtagene ciloleucel, sold under the brand name Yescarta, is a
medication used for the treatment for
large B-cell lymphoma
The large-cell lymphomas have large cells. One classification system for lymphomas divides the diseases according to the size of the white blood cells that have turned cancerous. A large cell, in this context, has a diameter of 17 to 20 μm. ...
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 cell
In biology, chimeric antigen receptors (CARs)—also known as chimeric immunoreceptors, chimeric T cell receptors or artificial T cell receptors—are receptor proteins that have been engineered to give T cells the new ability to target a specific ...
s (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
Cytokine release syndrome (CRS) is a form of systemic inflammatory response syndrome (SIRS) that can be triggered by a variety of factors such as infections and certain drugs. It refers to cytokine storm syndromes (CSS) and occurs when large numb ...
(CRS) and neurological toxicities.
[
Due to ]CD19
B-lymphocyte antigen CD19, also known as CD19 molecule ( Cluster of Differentiation 19), B-Lymphocyte Surface Antigen B4, T-Cell Surface Antigen Leu-12 and CVID3 is a transmembrane protein that in humans is encoded by the gene ''CD19''. In humans, ...
being a pan-B cell marker, the T-cells that are engineered to target CD19
B-lymphocyte antigen CD19, also known as CD19 molecule ( Cluster of Differentiation 19), B-Lymphocyte Surface Antigen B4, T-Cell Surface Antigen Leu-12 and CVID3 is a transmembrane protein that in humans is encoded by the gene ''CD19''. In humans, ...
receptors on the cancerous B cells[ also influence normal B cells, except some plasma cells.
]
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 (FDA) breakthrough therapy designation on 18 October 2017, for diffuse large B-cell lymphoma, transformed follicular lymphoma
Follicular lymphoma (FL) is a cancer that involves certain types of white blood cells known as lymphocytes. The cancer originates from the uncontrolled division of specific types of B-cells known as centrocytes and centroblasts. These cells normal ...
, 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
A therapy or medical treatment (often abbreviated tx, Tx, or Tx) is the attempted remediation of a health problem, usually following a medical diagnosis.
As a rule, each therapy has indications and contraindications. There are many different ...
of diffuse large B-cell lymphoma.[''F.D.A. Approves Second Gene-Altering Treatment for Cancer'' 2017]
/ref>[ ] It is not indicated for the treatment of patients with primary central nervous system lymphoma.
References
External links
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{{DEFAULTSORT:Axicabtagene Ciloleucel
Breakthrough therapy
Cancer treatments
Gene therapy
Gilead Sciences
Orphan drugs
Antineoplastic drugs