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.