First Cell-Based Gene Therapy for Mantle Cell Lymphoma Receives FDA Approval

For adults with disease unresponsive to other treatments or recurrent after another treatment, mantle cell lymphoma (Mantle Cell Lymphoma, MCL) can be treated with the cell-based gene therapy Tecartus (brexucabtagene autoleucel), which received approval on 24 July 2020 from the United States Food and Drug Administration (FDA). A chimeric antigen receptor (CAR) T-cell therapy, Tecartus is the first cell-based gene therapy approved by the FDA for MCL treatment and is a type of immunotherapy.

MCL, usually occurring in middle-aged or older adults, is a rare type of B-cell non-Hodgkin lymphoma. In MCL, the white blood cells that help the body fight infection, B cells, become cancerous, forming tumors in lymph nodes and rapidly spreading elsewhere in the body. MCL usually begins with enlarged lymph nodes and may spread to tissues such as bone marrow, liver and the gastrointestinal tract.

Each Tecartus dose is a customized treatment created using the patient's own immune system to help fight lymphoma. The patient's T cells, a type of white blood cell, are collected and genetically modified to contain a new gene that facilitates targeting and killing lymphoma cells. These modified T cells are then returned to the patient (the mechanism is explained in the infographic below).

Tecartus safety and effectiveness were assessed in 60 adults with refractory or recurrent MCL, followed for at least six months after their initial objective disease response, in a multicenter clinical trial.

After Tecartus treatment, the complete remission / response rate was 62% and the objective response rate was 87%.

This CAR T-cell therapy's side effects include cytokine release syndrome. This causes high fever and flu-like symptoms and is a systemic response to CAR T-cell activation, proliferation and neurological adverse effects. Both cytokine release syndrome and neurological adverse effects can be fatal or life-threatening. The most common Tecartus adverse effects are serious infections, low blood cell counts and a weakened immune system. Treatment side effects usually arise within the first one to two weeks after treatment, although some may develop later.

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In cancer, immunotherapy encompasses numerous methods used to activate the immune system against tumors. Many different methods and drugs are currently used for cancer immunotherapy; cellular immunotherapy is one of them.

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