The U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel, or liso‑cel) as the first‑ever CAR T‑cell therapy for adults with Marginal Zone Lymphoma (MZL) who have failed or relapsed after at least two prior lines of systemic therapy.
The approval expands the treatment landscape for MZL, a rare slow‑growing B‑cell non‑Hodgkin lymphoma that constitutes about 7 percent of all B‑cell NHL cases in the U.S., with roughly 7,460 new cases diagnosed each year.
Breyanzi works by harvesting a patient’s own T‑cells, genetically engineering them to target and kill cancerous B‑cells, and re-infusing them as a one‑time infusion after preparatory chemotherapy.
The decision is based on results from the MZL cohort of the global phase‑2 trial TRANSCEND FL (NCT04245839), in which 66 patients with relapsed or refractory MZL and prior therapy history received the specified dose of liso‑cel. Among them, 95.5 percent experienced an objective response and 62.1 percent achieved complete remission on imaging, with durable responses observed at a median follow-up of 21.6 months.
Common side effects included cytokine release syndrome (CRS), fatigue, musculoskeletal pain, diarrhea and headache. The therapy carries warnings, including risks of CRS, neurologic toxicities and secondary blood‑cell cancers, consistent with its potent immune‑based mechanism.
With this approval, Breyanzi becomes the only CD19‑directed CAR T‑cell therapy approved by the FDA for five different B‑cell cancers — expanding access for patients with limited options after multiple failed therapies
