�Novartis proclaimed that Gleevec� (imatinib mesylate) tablets has been given 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 given to therapies that could potentially fill up a presently unmet medical need and accelerates the standard review timing from ten to six months. Similar regulative submissions have been filed in the European Union and Switzerland and volition be filed in former 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 infection of kit-positive GIST reversive after surgical operation (adjuvant setting) in patients treated with Gleevec versus placebo.
In early 2007, the study met its primary efficaciousness endpoint, exhibit an advantage for Gleevec in recurrence-free survival. At that sentence, following the recommendation of the sovereign study data monitoring citizens committee to arrest the visitation 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 operative resection, or removal of their tumors. Of those who have the surgery, about half will suffer a return. If approved for this indication, Gleevec will be the first treatment option available to GIST patients after surgical process to reduce the risk of exposure of disease recurrence or to maybe prevent the disease from returning.
"The dramatic clinical results from this study of Gleevec in the ancillary GIST mount 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 sanctioned, the consumption of Gleevec for the treatment of GIST in the adjuvant setting would add to its eight-spot current indications, which include Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) and five former 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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