The United States Food and Drug Administration approved Gilead’s cell-based gene therapy Tecartus (brexucabtagene autoleucel). The drug approved for treating mantle cell lymphoma (MCL). Tecartus is a CAR T cell therapy, the first therapy approved by the FDA for the treatment of MCL.
Mechanism of action: The patient’s T cells will be extracted from the blood and will be genetically modified to include a new gene that enables the T cells to target and kill the lymphoma cells. These genetically modified T cells will be infused into the patient.
The approval is based in the ZUMA-2 trial, single-arm open-label study, evaluated in 60 adults with refractory or relapsed MCL. 62% of the patients had a complete response rate, whereas 87% of the patients had an objective response.
The drug might cause cytokine release syndrome, which causes fever, flu-like symptoms, and neurological toxicities. The risk mitigation measures were similar to Gilead’s other CAR T therapy Yescarta.
FDA has asked for further long-term safety studies.
The product prior received the Accelerated Approval pathway, Priority Review designation, and Breakthrough Therapy designation.
Mantle cell lymphoma is a rare form of B-cell non-Hodgkin’s lymphoma. The cancer is more prevalent in middle-aged or older adults, predominantly affects men of age over 60 years.