Bristol Myers Squibb Receives Approval for Breyanzi as the First CAR T Cell Therapy for 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® (lisocabtagene maraleucel; liso-cel) to treat adults with relapsed or refractory marginal zone lymphoma (MZL) who have undergone at least two previous lines of systemic therapy.
MZL accounts for around 7% of non-Hodgkin lymphoma cases, with most patients diagnosed at a median age of 67. The disease develops when white blood cells cluster in lymph nodes or organs. While early treatment often leads to remission, relapse is frequent, and a small proportion of cases progress to a more aggressive form known as diffuse large B-cell lymphoma.
Breyanzi is a CD19-directed CAR T cell therapy featuring a 4-1BB costimulatory domain designed to support cell expansion and persistence. It is administered once, following a structured process involving cell collection, potential bridging therapy, lymphodepletion, infusion and monitoring.
This approval makes Breyanzi the first authorised CAR T cell therapy for this patient group and expands its use across five different B-cell cancers. The decision is supported by results from the MZL cohort of the TRANSCEND FL study, a global Phase 2, open-label, single-arm trial.
According to the U.S. Prescribing Information, among 66 patients treated in the third-line and later setting, the therapy achieved an overall response rate of 95.5%, with 62.1% of patients showing a complete response. The median duration of response has not yet been reached, and most responders remained in remission at 24 months.
Marginal zone lymphoma is an indolent subtype of non-Hodgkin lymphoma. While initial treatment often works well, many patients eventually relapse, sometimes multiple times over several years. This contributes to a growing need for new treatment options that offer durable clinical benefit.
The safety profile observed in the MZL cohort was consistent with results seen in other Breyanzi studies. Cytokine release syndrome occurred in 76% of patients, with 4.5% experiencing severe cases. Neurological effects such as headache, tremor, encephalopathy, dizziness and aphasia were also reported, with severe cases being uncommon. Patients in the study were treated in both inpatient and outpatient settings, reflecting the therapy’s suitability for outpatient care in appropriate cases.
Breyanzi is covered by major commercial and government insurance programmes in the United States. Bristol Myers Squibb provides patient support services, including Cell Therapy 360, a digital platform offering information, treatment updates and resources for patients, carers and healthcare professionals.
Breyanzi is manufactured using a patient’s own T cells, which are collected, genetically modified and expanded before being re-infused.
The full treatment process includes blood collection, CAR T cell preparation, lymphodepletion, administration and monitoring for side effects.
Source: bms.com
