FDA Approves Bristol Myers Squibb’s Breyanzi for Marginal Zone Lymphoma

The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy, for adults with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy. Breyanzi is administered as a one-time infusion.

“The FDA approval of Breyanzi for relapsed or refractory marginal zone lymphoma further solidifies it as the leading CD19-directed CAR T cell therapy covering the broadest range of B-cell malignancies,” said Lynelle B. Hoch, president of Cell Therapy Organization at Bristol Myers Squibb. “Breyanzi is the first and only CAR T cell therapy approved for this patient population.”

The approval is based on data from the MZL cohort of the TRANSCEND FL study, an open-label, multicenter trial. Among 66 patients in the primary efficacy analysis, the overall response rate was 95.5%, with a complete response rate of 62.1%. Median duration of response was not reached, with 90.1% of responders maintaining response at 24 months.

Safety findings were consistent with prior indications, with cytokine release syndrome occurring in 76% of patients and Grade ≥3 events in 4.5%. Breyanzi is covered by commercial and government insurance programs, and Bristol Myers Squibb offers support services through its Cell Therapy 360 platform.