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From the Food and Drug Administration
July 4, 2001

New Treatment for Chronic Myelogenous Leukemia

JAMA. 2001;286(1):35. doi:10.1001/jama.286.1.35

The FDA has approved imatinib mesylate capsules (Gleevec, Novartis Pharmaceuticals Corp, East Hanover, NJ), a drug that targets bcr-abl tyrosine kinase, an enzyme that is regarded as the cause of Philadelphia chromosome–positive chronic myelogenous leukemia (CML). Gleevec received orphan product designation and accelerated approval for treatment of CML in blast crisis, accelerated phase, and chronic phase after failure of interferon treatment. The FDA's 2½-month review of Gleevec was the fastest ever for a cancer drug (JAMA. 2001;285:2841-2842).

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