Bristol Myers Squibb’s Breyanzi Receives U.S. FDA Approval as the First CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma
Friday, December 05, 2025
Bristol Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) for Breyanzi® a CD19-directed CAR T cell therapy. The treatment is authorised for adults with relapsed or refractory marginal zone lymphoma (MZL) who have already received at least two previous systemic therapies. Breyanzi is given as a single infusion. Important Safety Information, including Boxed Warnings for CRS, neurological side effects and secondary blood cancers, should be referred to in the prescribing details.
The approval positions Breyanzi as the only CAR T cell therapy available for this specific patient group. It also expands the therapy’s reach across a wider range of B-cell cancers, reflecting Bristol Myers Squibb’s continued focus on innovative cell-based treatments.
The decision is supported by results from the MZL cohort of the TRANSCEND FL study, an open-label, multicentre, multi-cohort, single-arm trial. According to U.S. Prescribing Information, among patients treated in the third-line or later setting (n=66), the overall response rate was 95.5%, with more than 60% achieving a complete response. The median duration of response was not reached, and over 90% of responders maintained their response at 24 months.
Marginal zone lymphoma, a slow-growing form of non-Hodgkin lymphoma, often responds well to initial treatment. However, some patients experience repeated relapses over many years, creating a need for new treatment choices that offer long-lasting results. The approval of Breyanzi provides an option with high response rates and a known safety profile.
The safety results in relapsed or refractory MZL were consistent with findings in other studies of Breyanzi. In the TRANSCEND FL MZL cohort, cytokine release syndrome of any grade was reported in 76% of patients, with severe cases in 4.5%. Neurological effects included headache, tremor, encephalopathy, dizziness and aphasia. The therapy can be administered in both inpatient and outpatient settings, depending on patient suitability.
Breyanzi is widely covered by commercial and government health insurance in the U.S. The company also provides patient support programmes, including Cell Therapy 360, a digital platform offering access to treatment information, manufacturing updates and resources for patients, care partners and physicians.
Source: businesswire.com
