Novartis' Glivec granted priority review status by US FDA

Swiss drug major Novartis' Glivec (imatinib) has been granted priority review status by the US Food and Drug Administration as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors. Similar regulatory submissions have been submitted in the European Union and Switzerland and will be filed in other countries shortly. The Glivec submissions are based on data from a Phase III, double-blind, randomized, multicenter, international study of more than 700 GIST patients who had surgery to remove their tumors. The results showed a dramatic 89% reduction in risk of GIST returning after surgery (adjuvant setting) in patients treated with Glivec versus placebo. In early 2007, the study met its primary efficacy endpoint, showing an advantage for Glivec in recurrence-free survival.