This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryAlemtuzumab receives accelerated approval May 7 for treatment of B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and who have failed fludarabine (Berlex's Fludara) therapy. The company is considering whether to study Campath in combination with Fludara, and in sequential use following Fludara, for first-line treatment of patients with B-cell CLL. Studies of the agent are planned in prolymphocytic leukemia, multiple sclerosis and organ transplantation
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