The Food and Drug Administration (FDA) approved Breyanzi (lisocabtagene maraleucel) for the treatment of patients with relapsed or refractory follicular lymphoma who have previously been treated with two or more lines of therapy, according to an announcement from the agency.
The approval is based off findings from the phase 2 TRANSCEND-FL trial, which included patients who had been treated with two or more systemic therapies, including an anti-CD20 antibody and alkylating agent. To be eligible, patients had to have adequate bone marrow function and be able to perform their daily tasks independently.
One of main goals of the trial was to investigate the overall response rate (ORR), which is the percentage of patients whose disease shrunk (known as a partial response) or disappeared (known as a complete response). The ORR was 95.7%. The other main goal of TRANSCEND-FL was duration of response, which is how long patients live after treatment without complications from the disease. At a median follow-up of 16.8 months, the duration of response was not reached, as not enough patients experienced disease complications for the researchers to calculate an average.
Breyanzi is a CAR-T cell therapy. This type of treatment works by extracting patients’ cells, engineering the T cells to find and fight cancer, growing them and then infusing them back into the patient. Before the infusion of the new cells, patients must undergo lymphodepletion, which kills off existing T cells remaining in the body.
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The most common side effects that occurred in 20% or more of patients on the TRANSCEND-FL study included cytokine release syndrome (a potentially serious condition that includes a increase in inflammatory markers, called cytokines, in the blood), musculoskeletal pain, fatigue, constipation and fever.
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