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

Gleevec™ (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 Orph...

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Bibliographic Details
Published in:The oncologist (Dayton, Ohio) Ohio), 2002-01, Vol.7 (5), p.390-392
Main Authors: Cohen, Martin H., Moses, Marie L., Pazdur, Richard
Format: Article
Language:English
Subjects:
Accelerated approval regulations
Antineoplastic Agents - therapeutic use
Benzamides
Chronic myelogenous leukemia
Drug Approval - legislation & jurisprudence
Food and Drug Administration
Gleevec
Humans
Imatinib Mesylate
Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy
Orphan Drug Production - legislation & jurisprudence
Orphan drug regulations
Piperazines - therapeutic use
Pyrimidines - therapeutic use
United States
United States Food and Drug Administration
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Description
Summary:Gleevec™ (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.
ISSN:1083-7159
1549-490X
DOI:10.1634/theoncologist.7-5-390