In July 2020, the FDA approved Tecartus (brexucabtagene autoleucel; from Kite Pharma), a CAR T-cell therapy, for the treatment of adults with mantle-cell lymphoma whose disease has not responded to or has relapsed after other therapies. Tecartus is the first gene therapy approved by the FDA specifically for the treatment of patients with mantle-cell lymphoma, a rare type of B-cell non-Hodgkin’s lymphoma.
Commenting on this FDA approval, Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research, said, “This approval is yet another example of customized treatments that use a patient’s own immune system to help fight cancer, while using a scientific advance in this promising new area of medicine. We’re seeing continued advances in the field of gene therapy and remain committed to supporting innovation in this promising new area of medicine.”
The FDA approved Tecartus based on results from a multicenter clinical trial of 60 adults with relapsed or refractory mantle-cell lymphoma who were followed for 6 months or longer after their first response to treatment. Overall, 87% of the patients had a response to therapy with Tecartus, including 62% of patients who reached remission (no cancer).
Like all gene therapies, Tecartus is made from the patient’s own immune system by collecting the patient’s cells and genetically modifying them to target the lymphoma cells. These modified T-cells are then infused back into the patient.
The most common side effects reported with Tecartus were serious infections, low blood cell counts, and a weakened immune system. Side effects usually appear within the first 1 to 2 weeks after treatment, but some adverse reactions may occur later. Of note, Tecartus can lead to cytokine release syndrome, a life-threatening condition.