FDA approves update to Gleevec label, extending treatment to certain GIST patients

February 6, 2012

Following a priority review, FDA has approved an update to imatinib mesylate (Gleevec, Novartis) 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.

Following a priority review, FDA has approved an update to imatinib mesylate (Gleevec, Novartis) 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 approval was based on data from an international, multicenter, open-label, phase 3 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

In addition, 36 months of Gleevec treatment resulted in a 55% reduction in the risk of death compared to one year of treatment (P=.0187). The median time of follow-up was 42 months for RFS and 48 months for OS.

“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,” Hervé Hoppenot, president, Novartis Oncology, said in a company press release. “With the significant survival benefit resulting from 3 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 3 years of adjuvant therapy with Gleevec for patients with high-risk GIST.

In addition to extending the Gleevec label to 3-year treatment duration in patients with KIT+ GIST after surgery, FDA has agreed that all accelerated post-approval commitments for this indication have been met, confirming the clinical benefit of adjuvant treatment with Gleevec.