Novartis’s Gleevec® (imatinib mesylate) has been approved by the United States Food and Drug Administration for treatment following the complete surgical removal of Kit (CD117)-positive gastrointestinal stromal tumors (GIST) in adults.
This new indication now gives Gleevec nine approved indications, including the treatment of Philadelphia chromosome-positive chronic myeloid leukemia, Kit (CD117)-positive GIST that is inoperable and/or has metastasized, as well as five other rare diseases.
Gleevec received priority review status in August 2008 for the newly approved indication and is the only agent approved as post-surgical therapy for GIST to delay recurrences.
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