The U.S. Food and Drug Administration (FDA) Approves Lisocabtagene Maraleucel for Relapsed or Refractory Marginal Zone Lymphoma

December 5, 2025 – On December 5, 2025, the U.S. Food and Drug Administration (FDA) announced it has approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.

Lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) is an immunotherapy approach, called chimeric antigen receptor (CAR) T cell therapy, that uses patients’ own immune cells to treat their cancer.

CAR T cell therapy provides engineered molecules called chimeric antigen receptors (CARs) that recognize and destroy antigens present on the surface of lymphoma cells. T cells are removed from patients and genetically modified to produce CARs. The genetically engineered CAR T cells are grown in the laboratory until they number in the billions and are then infused back into the patient.

“The FDA’s decision to approve lisocabtagene maraleucel marks a crucial milestone for patients with relapsed or refractory marginal zone lymphoma,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “MZL is a rare subtype of lymphoma, and this approval brings a much-needed new option to a community with limited choices and represents new hope for patients diagnosed with this disease.”

For more information on the FDA approval of lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company), visit the FDA’s website. To learn more about treatment options for marginal zone lymphoma, visit the Foundation’s chronic lymphocytic leukemia or small lymphocytic lymphoma learning center.