Gleevec(imatinib mesylate) Receives FDA Priority Review As First Therapy To Reduce Recurrence Of Gastrointestinal Stromal Tumors After Surgery
Novartis announced 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). FDA 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. Similar regulatory submissions have been filed in the European Union and Switzerland and will be filed in other countries shortly.
The Gleevec (imatinib mesylate) 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 (imatinib mesylate) versus placebo.
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.
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. 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.
“The dramatic clinical results from this study of Gleevec in the adjuvant GIST setting are especially encouraging when we consider the incremental benefit we typically see with other adjuvant therapies for solid tumors,” said Rainer Boehm, MD, Executive Vice President, North American Region Head, Novartis Oncology. “The adjuvant use of Gleevec, if approved, would represent an important advance in the ongoing post-surgery management of GIST.”
Gleevec is currently indicated in both the US and EU for the first-line treatment of metastatic or unresectable (inoperable) kit-positive GIST. If approved, the use of Gleevec for the treatment of GIST in the adjuvant setting would add to its eight current indications, which include Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) and five other rare diseases. Novartis also has a therapy for the treatment of carcinoid tumors and acromegaly and multiple treatments in the pipeline targeting rare diseases.
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