FDA extends Novartis' Gleevec label to three-year treatment in patients with KIT+ GIST after surgery

Novartis announced today that following a priority review, the US Food and Drug Administration (FDA) 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 (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial. This treatment regimen has been shown to improve recurrence-free survival (RFS) and overall survival (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 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.

"This approval represents another important step in the progress of KIT+ GIST treatment that began a decade ago when Gleevec was first approved to treat metastatic KIT+ GIST," said Herve Hoppenot, President, Novartis Oncology. "With the significant survival benefit resulting from three years of adjuvant treatment, GIST patients now have a more effective regimen to help manage their disease."

Gastrointestinal stromal tumors are a rare, life-threatening cancer of the gastrointestinal tract. The major cause of GIST is an abnormal form of the protein KIT which causes cells to grow uncontrollably and become cancerous. Patients with GIST are at risk of recurrence following complete resection of primary GIST.

In August 2011, the US National Comprehensive Cancer Network (NCCN) updated its clinical practice guidelines to recommend consideration of at least three years of adjuvant therapy with Gleevec for patients with high-risk GIST.

In addition to extending the Gleevec 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 Gleevec.