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Campath granted regular approval
Genzyme Corp. and Bayer HealthCare Pharmaceuticals have announced that alemtuzumab (Campath) has been granted regular approval by the FDA. The monoclonal antibody is indicated as a first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL) and was initially approved in 2001 under accelerated approval regulation. The final nod was given by the agency after review of study results submitted to fulfill the postmarketing commitment showed clinical benefit. Data from a phase III trial comparing the therapy with chlorambucil (Leukeran, GlaxoSmithKline) showed a longer progression-free survival in patients receiving alemtuzumab. Patients treated with alemtuzumab had a 42% reduction in risk of disease progression or death.