Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed … – The Bakersfield Californian

Posted: May 18, 2024 at 2:41 am

PRINCETON, N.J.--(BUSINESS WIRE)--May 15, 2024--

Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for 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 follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. 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). Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN ) Clinical Practice Guidelines in Oncology (NCCN Guidelines ) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.*

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Bristol Myers Squibb's CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed ... - The Bakersfield Californian

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