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On February 17, 2022, Bristol-Myers Squibb (BMS) announced that the U.
Breyanzi is an autologous CAR-T cell therapy targeting the CD19 antigen with a well-defined composition and 4-1BB co-stimulatory domain
This application is based on positive results from a pivotal Phase 3 clinical trial
Trial results showed that patients in the Breyanzi group achieved highly statistically and clinically meaningful improvements in event-free survival (EFS), complete response rate (CRR), and progression-free survival (PFS) compared to the standard-of-care group , and overall survival (OS) showed a positive trend
References:
[1] US Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb's Supplemental Biologics License Application for Breyanzi (lisocabtagene maraleucel) as a Second-Line Therapy for Relapsed or Refractory Large B-cell Lymphoma.
(Original abridged)