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Gleevec^TM for the Treatment of Chronic Myelogenous Leukemia: U.S. Food and Drug Administration Regulatory Mechanisms, Accelerated Approval, and Orphan Drug Status

Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research and Office of Orphan Products Development, Office of the Commissioner, Food and Drug Administration, Rockville, Maryland, USA

Correspondence: Martin H. Cohen, M.D., Food and Drug Administration, HFD-150, 5600 Fishers Lane, Rockville, Maryland 20857, USA. Telephone: 301-594-2473; Fax: 301-594-0499; e-mail: cohenm{at}cder.fda.gov

Gleevec^TM (imatinib mesylate), a highly promising new drug for the treatment of chronic myelogenous leukemia in blast crisis, in accelerated phase, and in chronic phase after interferon failure or intolerance, received orphan drug status from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development on January 31, 2001, and accelerated approval from the FDA for the above three indications on May 10, 2001. The purpose of this report is to summarize FDA regulatory mechanisms, i.e., accelerated approval and orphan drug regulations, that have permitted patients to receive this drug as rapidly as possible.

Key Words. Gleevec • Imatinib mesylate • Chronic myelogenous leukemia • Food and Drug Administration • Accelerated approval regulations • Orphan drug regulations

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