Bristol Myers Squibb's Breyanzi® Approved By U.S. FDA As The First And Only CAR T Cell Therapy For Adults With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma
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Bristol Myers Squibb's Breyanzi has been approved by the U.S. FDA as the first and only CAR T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This approval marks a significant advancement in treatment options for patients with these conditions, offering a one-time infusion that has shown deep and durable responses. In the TRANSCEND CLL 004 trial, 20% of patients achieved a complete response, with the median duration of response not yet reached. Breyanzi is also approved for relapsed or refractory large B-cell lymphoma, expanding its potential patient base.

March 15, 2024 | 5:28 am
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Bristol Myers Squibb's Breyanzi receives FDA approval for treating CLL/SLL, marking a significant expansion in its treatment portfolio.
The FDA approval of Breyanzi for CLL/SLL represents a significant milestone for Bristol Myers Squibb, potentially leading to increased revenues and market share in the CAR T cell therapy space. This approval not only strengthens BMY's position in oncology but also highlights its commitment to advancing cancer treatment. The positive trial results and the uniqueness of Breyanzi as the only CAR T cell therapy for CLL/SLL patients are likely to generate significant interest among healthcare providers and patients, translating into a positive short-term impact on BMY's stock.
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