Lisocabtagene Maraleucel Approved for Follicular Cancer
The CAR T-cell therapy received accelerated approval to treat advanced cases of pretreated follicular lymphoma.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to lisocabtagene maraleucel (Breyanzi) for the treatment of adult patients with relapsed or refractory follicular lymphoma who have already received at least two lines of systemic therapy.
Lisocabtagene maraleucel is a chimeric antigen receptor (CAR) T-cell therapy, a type of immunotherapy in which a patient’s own T cells (a type of immune cell) are removed, modified in the lab to recognize a target protein, and then infused back into the patient to find and kill cancer cells. Lisocabtagene maraleucel is designed to target the CD19 protein that is highly expressed by malignant B cells, including follicular lymphoma cells.
Lisocabtagene maraleucel was approved to treat chronic lymphocytic leukemia and small lymphocytic leukemia in March 2024 and large B-cell lymphoma in June 2022. The current approval makes it the third CD19-directed CAR T-cell therapy approved for relapsed or refractory follicular lymphoma, after axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah).
The approval is based on results from TRANSCEND-FL, an open-label, multicenter, single-arm, phase II trial that enrolled patients with relapsed or refractory follicular lymphoma who had received at least two prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating chemotherapy.
Among 94 evaluable patients, 95.7% experienced an objective response, and the median duration of response was not reached after a median follow up of 16.8 months.
The recommended dose for lisocabtagene maraleucel is 90×106 to 110×106 viable CAR T cells administered two to seven days after chemotherapy pretreatment, which depletes the patient’s existing immune cells.
The prescribing information for lisocabtagene maraleucel includes a boxed warning for fatal or life-threatening cytokine release syndrome, neurologic toxicities, and secondary blood cancers.
Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma that begins in B cells. According to federal statistics, it was estimated that 80,620 individuals would be diagnosed with non-Hodgkin lymphoma and 20,140 patients would die of the disease in the United States in 2024.
The FDA rendered its decision on May 15, 2024. Accelerated approval means that continued approval may be contingent upon a confirmatory trial.
