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FDA Grants Accelerated Approval for BMS’ Breyanzi in CLL, SLL

Complete response rate associated with Breyanzi treatment was 20% with median duration of response 35.3 months.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Bristol Myers Squibb was granted accelerated approval by the U.S. FDA for Breyanzi  (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy.    This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indicat...

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