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US FDA approved BMS gene therapy Breyanzi

The US Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel). Breyanzi is a gene therapy for treating patients with large B-cell lymphoma, for patients who have relapsed cancer or had at least two other prior systemic treatment types.

Breyanzi is a chimeric antigen receptor T (CAR-T) cell therapy, a third cell and gene therapy approved for treating non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). It cannot be indicated for primary central nervous system lymphoma.

DLBCL is the most common non-Hodgkin lymphoma in adults, which can be either fast-growing or slow-growing.

Breyanzi is customized patient’s T-cells to fight lymphoma. The T-cells are genetically modified to add a gene that kills the lymphoma cells.

More than 250 patients with refractory or relapsed large B-cell lymphoma were treated in multicenter clinical trials; the remission rate was 54%. The drug has shown an overall response rate of 73%. The median duration of response was 16.7 months.

Treating Breyanzi can lead to cytokine release syndrome (CRS); activation and proliferation of CAR T cells lead to CRS. CRS and neurological disorders can lead to life-threatening conditions. Grade ≥3 cytokine release syndrome occurred in 4% of patients and Grade ≥3 neurologic toxicities in 12% of patients.



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