Novartis announced that the FDA has approved an update to the Gleevec (imatinib mesylate tablets) labeling to recommend an extended treatment period for certain patients with gastrointestinal stromal tumors (GIST) following surgery. It is now recommended that Gleevec be administered as adjuvant therapy for 36 months after complete gross resection of GIST for adult patients with KIT (CD117)-positive GIST.
This approval was based on data from a Phase 3, international, multicenter, open-label clinical trial in 397 patients that demonstrated that 36 months of Gleevec treatment significantly prolonged recurrence-free survival compared to 12 months of Gleevec treatment, which was a 54% reduction in the risk of recurrence (P<0.0001). In addition, 36 months of Gleevec treatment resulted in a 55% reduction in the risk of death compared to one year of treatment (P=0.0187).
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