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FDA Expands Approval For Bristol Myers Squibb's Breyanzi, Making CAR T Cell Therapy Available For Broadest Range Of B-Cell Malignancies

On Thursday, the FDA approved Bristol Myers Squibb Co’s (NYSE:BMY) Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy. This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved, making it the CAR T cell therapy available to treat the broadest array of B-cell malignancies. In March, the FDA granted accelerated approval for Breyanzi for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Earlier ...