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Gleevec Gets FDA Priority Review for First-Line Use in Early CML

Gleevec Gets FDA Priority Review for First-Line Use in Early CML

EAST HANOVER, New Jersey—Novartis Oncology’s Gleevec (ima-tinib mesylate) has been granted priority review by the FDA for use as first-line treatment for newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. The previous indication allowed for the treatment only in the later stages of the disease or in chronic phase after interferon-alfa failure. The FDA also granted priority review to an application by Novartis to provide dosing information for Gleevec in pediatric patients with Ph+ CML. Both applications will be decided by December 28, 2002, the company said in a news release.

 
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