Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) announced late Thursday that it has received US Food and Drug Administration (FDA) approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy, for adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) after at least two prior systemic treatments.

Breyanzi is administered as a single infusion following a standard CAR T treatment process.

The FDA approval is based on the TRANSCEND FL study, in which Breyanzi achieved a 95.5% overall response rate in the primary efficacy set, including a 62.1% complete response rate. Median duration of response was not reached, with 90.1% of responders maintaining benefit at 24 months.

Breyanzi's safety profile in this population was consistent with earlier studies, with cytokine release syndrome occurring in 76% of patients and manageable rates of neurologic events.

The therapy is now the only FDA-approved CAR T cell option across five cancer types.

Breyanzi is widely covered by US insurance programmes, and Bristol Myers Squibb supports patient access through assistance services and its Cell Therapy 360 platform.