BMS’s Breyanzi Receives FDA Approval in Relapsed/Refractory Marginal Zone Lymphoma
Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi® (lisocabtagene maraleucel), a CD19-directed CAR T cell therapy, for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior systemic treatments.
Breyanzi is the first and only CAR T cell therapy approved for this patient population and is given as a one-time infusion.
The approval is based on results from the MZL cohort of the TRANSCEND FL study, an open-label, multicentre clinical trial. Among patients treated in the third-line or later setting, the overall response rate was 95.5%, with a complete response rate of 62.1%.
Most responding patients remained in response at 24 months, and the median duration of response had not yet been reached.
The safety profile of Breyanzi in MZL was consistent with previous studies in other blood cancers. Cytokine release syndrome occurred in most patients, with severe cases reported in a small proportion.
Neurological side effects such as headache, tremor and encephalopathy were observed, with few high-grade events. Treatment was delivered in both inpatient and outpatient settings.
Breyanzi is widely covered by U.S. commercial and government insurance programmes. Bristol Myers Squibb provides additional patient and clinician support through dedicated access, education and digital care services to support the CAR T cell treatment pathway.
