Another CAR-T therapy
The first CAR-T therapy for the treatment of mantle cell lymphoma has been approved
U.S. Food and Drug Administration (FDA) approved gene cell therapy Tecartus (brexucabtagene autoleucel) companies Kite Pharma (part of Gilead Company), which is the first T-cell therapy for the treatment of adult patients with recurrent or refractory mantle cell lymphoma (MCL) who have not responded to other treatments.
Mantle cell lymphoma is a malignant tumor of B–lymphocytes (cells of the immune system). It refers to the so-called non-Hodgkin's lymphomas, when a malignant tumor occurs not only in the lymph nodes, but also in the tonsils, spleen and other organs of the immune system.
According to the FDA, "this approval is another example of a patient-centered treatment that uses a person's own immune system to help him fight cancer, relying on scientific progress in this new field of medicine (approx. – gene therapy)".
Each dose of Tecartus is an individual treatment created using the patient's own immune system cells. The patient's T cells are harvested and genetically modified to include a new gene that makes it easier to target and destroy lymphoma cells. These modified T cells (a type of white blood cell) are then injected back into the patient.
The safety and efficacy of Tecartus were established in a multicenter clinical trial involving 60 adult patients with refractory or recurrent MCL who were observed for at least six months after their first objective response to the disease. A single administration of the drug led to complete remission in 62% of patients, and the objective response rate was 87%.
The instructions in the drug contain a warning about cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR-T cells, causing high fever and flu-like symptoms, as well as neurological problems. Cytokine release syndrome can be fatal or life-threatening.
Because of the CRS risk, Tecartus is approved with a Risk Assessment and Mitigation Strategy (REMS) that includes elements of Safe Use Assurance (ETASU). The risk reduction measures for Tecartus are identical to the measures of the current REMS program for another CAR-T therapy – Yescarta.
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