FDA nod for Breyanzi as first CAR T therapy for r/r marginal zone lymphoma

The US Food and Drug Administration has approved Bristol Myers Squibb’s (NYSE: BMY) Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory (r/r) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. Breyanzi is administered as a one-time infusion.

With this latest approval, Breyanzi becomes the only CAR T cell therapy approved by the FDA for five different cancer types, the most of any CD19-directed CAR T cell therapy, said BMS, whose shares edged up 2% to $51.95 on the news.

“Today’s approval represents a major advancement in precision medicine, essentially turning the patient’s immune system into a more effective tool to treat MZL,” Dr Vinay Prasad, chief medical and scientific officer and director of the FDA’s Center for Biologics Evaluation and Research. “The FDA continues to optimize its regulatory authority to expand treatment options in the fight against cancer.”