From Earlier: FDA Approves Novartis Drug Gleevec Label Recommending Extending Treatment to Three Years for Certain GIST Patients After Surgery

Novartis (NYSE: NVS) announced today that following a priority review, the US Food and Drug Administration has approved an update to the Gleevec® (imatinib mesylate)[*] tablets label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors who met the risk of recurrence inclusion criteria of the pivotal trial. This treatment regimen has been shown to improve recurrence-free survival and overall survival for KIT+ GIST patients compared to 12 months of treatment(3).

The US approval was based on data from an international, multicenter, open-label, Phase III clinical trial. Results of the study showed that 36 months of Gleevec treatment significantly prolonged RFS 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). The median time of follow-up was 42 months for RFS and 48 months for OS(3).