Genzyme Corporation and Bayer HealthCare have submitted a supplemental biologics license application (sBLA) for their agent Campath® (alemtuzumab) to the United States Food and Drug Administration (FDA).
The sBLA is to include the use of Campath as first-line therapy in the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Currently, Campath is approved for the treatment of patients with B-CLL who have received prior therapy with an alkylating agent and have failed prior treatment with Fludara® (fludarabine).
The sBLA submission is based on results from a phase III clinical trial directly comparing Campath to chlorambucil (Leukeran®) as initial therapy for the treatment of B-CLL.
Campath is a monoclonal antibody that is targeted against the CD52 antigen.
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