FDA Approves Campath® for First-Line Treatment of B-cell CLL
In October of 2007 the US Food and Drug Administration (FDA) approved Campath (alemtuzumab) for initial treatment for patients with chronic lymphocytic leukemia (CLL).[1] This is the first monoclonal antibody approved by the FDA for B-cell CLL. Campath was previously approved for treatment of patients with B-cell CLL whose disease has stopped responding to alkylating agents and Fludara. Approval was based on interim results from an international phase III trial which demonstrated that Campath provided significantly superior responses with a favorable toxicity profile when compared with chlorambucil as initial therapy of B-cell CLL. These results were recently presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO).[2]
[2]Hillmen P, Skotnicki A, Tobak T, et al. Preliminary Phase III Efficacy and Safety of Alemtuzumab vs Chlorambucil as Front-Line Therapy for Patients with Progressive B-Cell Chronic Lymphocytic Leukemia (BCLL). Proceedings from the 42nd annual meeting of the American Society of Clinical Oncology. Atlanta, Ga. June 2006. Abstract # 6511.
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