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News From the Food and Drug Administration
March 6, 2002

New Indication for Gleevec

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JAMA. 2002;287(9):1103. doi:10.1001/jama.287.9.1103-JFD20003-2-1

The FDA has approved imatinib mesylate capsules (Gleevec, Novartis Pharmaceutical Corp, East Hanover, NJ), an approved treatment for chronic myeloid leukemia, for the treatment of patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).

The new indication was approved on the basis of an open-label, randomized study in 147 patients with unresectable or metastatic malignant GIST who were randomized to receive either 400 mg or 600 mg of the drug daily for up to 24 months. Primary evidence of efficacy was based on objective response rates.