(ChemotherapyAdvisor) – The U.S. Food and Drug Administration has approved an update to the Gleevec (imatinib mesylate) tablets label to recommend 36 months of treatment after surgery in adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who are at risk of recurrence.

The updated label will reflect data from an international, multicenter, open-label Phase 3 clinical trial of imatinib that demonstrated a 54% reduction in risk of recurrence for those treated with imatinib for 36 vs. 12 months (P<0.0001). At 60 months, 92% of patients who received 36 months of imatinib were alive vs. 82% who received 12 months of imatinib.

“Although originally approved in the metastatic disease setting, this subsequent trial has demonstrated that longer use of Gleevec can prolong patient’s lives in earlier disease settings,” said Richard Pazdur, MD, of the FDA’s Center for Drug Evaluation and Research.

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The most common adverse events observed in patients receiving imatinib include edema, nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.

In 2008, imatinib received accelerated approval for this use. Imatinib is marketed by Novartis Pharmaceuticals Corp.

ASCO 2011 Abstract

FDA Press Release

Novartis Press Release