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FDA Approves Novartis Drug Glivec Label - Quick Facts

Novartis AG (NVS) said the US Food and Drug Administration or FDA has approved an update to the Glivec label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors or GIST who met the risk of recurrence inclusion criteria of the pivotal trial. This treatment regimen improved recurrence-free survival or RFS and overall survival or OS for KIT+ GIST patients compared to 12 months of treatment.

The US approval was based on data from an international, multicenter, open-label, Phase III trial, with the study results demonstrating that 36 months of Glivec treatment significantly prolonged RFS compared to 12 months of Glivec treatment, which was a 54% reduction in the risk of recurrence. Moreover, 36 months of Glivec treatment resulted in a 55% reduction in the risk of death compared to one year of treatment.

Further to extending the Glivec label to three-year treatment duration in patients with KIT+ GIST after surgery, the FDA has agreed that all accelerated
post-approval commitments for this indication have been met, confirming the clinical benefit of adjuvant treatment with Glivec.

by RTT Staff Writer

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