On December 4, 2025, the FDA approved a new indication for Bristol Myer Squibb’s BREYANZI (lisocabtagene maraleucel) for the treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy.
BREYANZI is a chimeric antigen receptor T-cell (CAR T) therapy, which is a one-time treatment, that works by extracting a patient’s own T-cells, genetically modifying them, and reintroducing them to the patient where they target and kill cancer cells. BREYANZI is the first CAR T therapy indicated to treat MZL. According to the FDA, the approval was based on the TRANSCEND FL clinical trial where 95.5% of patients receiving treatment experienced a response, and 62.1% experienced a complete response. Responses were also durable after a median follow up of 21.6 months.
Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research commented that the “approval represents a major advancement in precision medicine, essentially turning the patient’s immune system into a more effective tool to treat MZL.”
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