Novartis announced today that Gleevec® (imatinib mesylate) tablets* has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST).
USFDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from ten to six months(1). Similar regulatory submissions have been filed in the European Union and Switzerland and will be filed in other countries shortly.
The Gleevec 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 kit-positive GIST returning after surgery (adjuvant setting) in patients treated with Gleevec versus placebo(2). (* Known as Glivec® (imatinib) outside the US, Canada and Israel.)
In early 2007, the study met its primary efficacy endpoint, showing an advantage for Gleevec in recurrence-free survival. At that time, following the recommendation of the independent study data monitoring committee to stop the trial accrual early, the study investigators made public the interim results and offered Gleevec to patients receiving placebo(3).
Approximately half of all patients with newly diagnosed GIST are considered candidates for surgical resection, or removal of their tumors. Of those who have the surgery, about half will suffer a recurrence(4). If approved for this indication, Gleevec will be the first treatment option available to GIST patients after surgery to reduce the risk of disease recurrence or to possibly prevent the disease from returning.