Bristol Myers Squibb has received approval from the U.S. Food and Drug Administration for Breyanzi, a CD19-directed CAR T cell therapy, for the treatment of adults with relapsed or refractory marginal zone lymphoma who have undergone at least two prior lines of systemic therapy.
With this approval, Breyanzi becomes the first and only CAR T cell therapy authorized in the United States for this patient population. It also represents the fifth cancer indication for Breyanzi, giving it the broadest approved use among CD19-directed CAR T therapies.
The FDA decision was supported by results from the marginal zone lymphoma cohort of the TRANSCEND FL clinical study, a Phase 2, open-label trial evaluating the therapy in patients with relapsed or refractory indolent B-cell lymphomas.
In the marginal zone lymphoma group, treatment with Breyanzi produced high response rates, with many patients achieving complete responses. Responses were durable, with a large proportion of responding patients remaining in remission at long-term follow-up.
The safety profile observed in this patient population was consistent with previous studies of Breyanzi across other lymphoma indications. Known CAR T-related risks, including cytokine release syndrome and neurologic events, were manageable and aligned with prior clinical experience.
Breyanzi is a personalized, one-time cell therapy manufactured from a patient’s own T cells that are genetically engineered to target CD19-positive cancer cells. The treatment process includes cell collection, manufacturing, conditioning chemotherapy, infusion, and post-treatment monitoring.
The approval strengthens Bristol Myers Squibb’s position in cell therapy and supports its strategy to expand access to CAR T treatments across a broader range of blood cancers.
Marginal zone lymphoma is a slow-growing form of non-Hodgkin lymphoma that often responds to initial therapy but can relapse multiple times over many years. The availability of an FDA-approved CAR T therapy provides a new treatment option for patients with limited alternatives.
Industry observers note that the approval reflects continued progress in cell therapy development and the expanding role of CAR T treatments beyond aggressive lymphomas into indolent disease settings.
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