Breyanzi (lisocabtagene maraleucel)
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FDA Approves Bristol-Myers Squibb’s Breyanzi as First-Ever CAR T Therapy for Rare Marginal Zone Lymphoma
Yahoo Finance· 2025-12-21 15:57
Core Insights - Bristol-Myers Squibb is identified as one of the best stocks to buy for the next five years, with Goldman Sachs raising its price target to $57 from $51 while maintaining a Neutral rating [1] Group 1: FDA Approval and Product Details - The US FDA approved Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory marginal zone lymphoma, marking it as the first CAR T cell therapy approved for this patient population [2] - Breyanzi achieved a remarkable overall response rate of 95.5% in the primary efficacy analysis of 66 patients, with 62.1% reaching a complete response, and 90.1% of responders maintaining their response at the 24-month mark [3] - The therapy is administered as a one-time infusion and is suitable for both inpatient and outpatient settings due to its established safety profile [3] Group 2: Safety and Additional Approvals - Safety data from the trial is consistent with previous studies, although Breyanzi carries Boxed Warnings for CRS, neurologic toxicities, and potential secondary hematological malignancies [4] - Beyond marginal zone lymphoma, Breyanzi is already approved for several other conditions, including large B-cell lymphoma and chronic lymphocytic leukemia [4] Group 3: Company Overview - Bristol-Myers Squibb is involved in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products globally, focusing on areas such as oncology, hematology, immunology, cardiovascular, and neuroscience [5]