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FDA Approves Bristol Myers Squibb's CAR T-cell Therapy Breyanzi for Large B-cell Lymphoma

NEW YORK – The US Food and Drug Administration on Friday approved lisocabtagene maraleucel (Bristol Myers Squibb's Breyanzi) as a treatment for relapsed or refractory large B-cell lymphoma.

Lisocabtagene maraleucel, an autologous CAR T-cell therapy developed by BMS subsidiary Juno Therapeutics, is the third CAR T to garner regulatory approval for certain types of non-Hodgkin lymphoma. The FDA based its approval on data from a clinical trial in which 250 patients with relapsed or refractory large B-cell lymphoma received lisocabtagene maraleucel. The complete remission rate was 54 percent.

"Today's approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens."

Before receiving lisocabtagene maraleucel, patients must have failed to respond to or relapsed after at least two other systemic treatments. The agency said that the therapy, which has orphan drug status, is not indicated for patients with primary central nervous system lymphoma. 

The FDA-approved label also carries a boxed warning for cytokine release syndrome (CRS). Because of this risk, the agency approved lisocabtagene maraleucel with a risk evaluation and mitigation strategy and is requiring healthcare facilities be certified and medical staff trained to dispense the treatment and manage these side effects.