The U.S. Food and Drug Administration (FDA) approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment, the agency said in a press release.
Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of MCL – a rare form of cancerous B-cell non-Hodgkin’s lymphoma that usually occurs in middle-aged or older adults. In patients with MCL, B-cells, a type of white blood cell, which help the body fight infection, change into cancer cells that start to form tumors in the lymph nodes and quickly spread to other areas of the body.
Each dose of Tecartus is a customized treatment created using a patient’s own immune system to help fight the lymphoma. The patient’s T cells, a type of white blood cell, are collected and genetically modified to include a new gene that facilitates the targeting and killing of the lymphoma cells. These modified T cells are then infused back into the patient.
The safety and efficacy of Tecartus was established in a multicenter clinical trial of 60 adults with refractory or relapsed MCL who were followed for at least six months after their first objective disease response. The complete remission rate after treatment with Tecartus was 62 percent, with an objective response rate of 87 percent.
The label carries a warning for 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, and for neurologic toxicities. Both CRS and neurologic toxicities can be fatal or life-threatening. The most common side effects of Tecartus include serious infections, low blood cell counts and a weakened immune system. Side effects from treatment usually appear within the first one to two weeks after treatment, but some side effects may occur later.
