BMY - FDA Approves Expanded Use Of Bristol Myers Squibb's Breyanzi Cancer Cell Therapy For Previously Treated Follicular Lymphoma | Benzinga
Wednesday, the FDA granted accelerated approval to 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 follicular lymphoma.
This indication is approved under accelerated approval based on response rate and duration of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
In April, following an investigation announced in November last year, the FDA said it would now require boxed warnings—the highest safety-related caution for medications—for all chimeric antigen ...