The U.S. Food and Drug Administration Approves Lisocabtagene Maraleucel (Breyanzi) for Mantle Cell Lymphoma

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On May 30, 2024, the U.S. Food and Drug Administration (FDA) announced it has approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory mantle cell lymphoma (MCL) who have received two or more prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi).

Lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) is a form of CAR T cell therapy. 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.

“This approval brings a new CAR T cell therapy option to patients facing relapsed or refractory MCL,” said Meghan Guttierez, CEO of the Lymphoma Research Foundation. “Each advance in treatment represents important progress in improving patient outcomes, and today’s news builds upon this progress with a new treatment for patients with limited options.”

For more information on the FDA approval of lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.), visit the FDA’s website

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