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JAMA. 2001;286:35.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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 2-month review of Gleevec was the fastest ever for a cancer drug (JAMA. 2001;285:2841-2842).

Gleevec was granted special status due to the lack of effective treatment for advanced-phase CML, a life-threatening disease that affects fewer than 50 000 people in the United States. The FDA may extend accelerated approval to therapies for the treatment of serious and life-threatening diseases in patients who are unresponsive to or intolerant of existing medications or to therapies for diseases for which no therapy exists.

Under the accelerated procedure, the . . . [Full Text of this Article]

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