Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)
Bristol-Myers Squibb Company (BMY)
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Source: Business Wire
In the MZL cohort of TRANSCEND FL, Breyanzi delivered deep and durable responses in 95.5% of patients while demonstrating a consistent safety profileBreyanzi is now the only CAR T cell therapy approved by the FDA for five cancer types, the most of any CD19-directed CAR T cell therapy PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of 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 (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. Breyanzi is administered as a one-time infusion*. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.This press release feature
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News
- Bristol Myers Squibb's Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL) [Yahoo! Finance]Yahoo! Finance
- Bristol Myers Squibb (NYSE:BMY) had its "sector perform" rating reaffirmed by analysts at Scotiabank.MarketBeat
- How faster decisions can transform patient care in Canada [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- Bristol Myers Squibb (NYSE:BMY) was given a new $65.00 price target on by analysts at Truist Financial Corporation.MarketBeat
- Terray Therapeutics Achieves AI-Enabled Drug Discovery Milestone in Collaboration with Bristol Myers SquibbBusiness Wire
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- 10/31/25 - Beat
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- 11/10/25 - Form 8-A12B
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