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Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery
Date:8/27/2008

- Clinical data showing unprecedented 89% reduction in risk of GIST relapse with use of Gleevec after surgery are basis for FDA, EMEA, Swissmedic

filings - Historically, one in two patients experienced recurrence of GIST after

surgery - Regulatory submissions reflect continued commitment to bringing new

therapeutic approaches to patients with rare diseases

EAST HANOVER, N.J., Aug. 27 /PRNewswire/ -- Novartis announced today that Gleevec(R) (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(1). Similar regulatory submissions have been filed in the European Union and Switzerland and will be filed in other countries shortly.

* Known as Glivec(R) (imatinib) outside the US, Canada and Israel.

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).

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 re
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SOURCE Novartis
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