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.
Schwetz BA. New Treatment for Chronic Myelogenous Leukemia. JAMA. 2001;286(1):35. doi:10.1001/jama.286.1.35