December 5, 2025 — Leads & Copy — The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s Breyanzi® (lisocabtagene maraleucel; liso-cel) for treating adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have undergone at least two prior lines of systemic therapy.
Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, is administered as a single infusion. The approval is based on results from the MZL cohort of the TRANSCEND FL study, an open-label, multicenter, single-arm study. In the study, patients treated with Breyanzi in the third-line plus setting had an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 62.1%. The median duration of response was not reached, with 90.1% of responders still in response at 24 months.
Dr. M. Lia Palomba, TRANSCEND FL study investigator from Memorial Sloan Kettering Cancer Center, noted the significance of this approval for patients experiencing multiple relapses of marginal zone lymphoma, highlighting the treatment’s high response rates and established safety profile.
The safety profile of Breyanzi in R/R MZL was consistent with previous trials. Cytokine release syndrome (CRS) occurred in 76% of patients, with Grade ≥3 CRS in 4.5%. Nervous system disorders, including headache, tremor, encephalopathy, and aphasia, were also reported. The treatment allows for outpatient administration and adverse event management for appropriate patients.
Bristol Myers Squibb offers various programs and resources, including Cell Therapy 360, to support patients throughout their CAR T cell therapy journey. Breyanzi is covered by commercial and government insurance programs in the U.S.
Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb, stated that this approval in a fifth cancer type demonstrates the company’s commitment to bringing cell therapy to more patients. Breyanzi has also been approved for other lymphoma types in Japan, the European Union, Switzerland, Israel, the United Kingdom, and Canada.
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Bristol Myers Squibb
