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Positive Results Prompt US National Cancer Institute to Make,Gleevec Available To Patients in Post-Surgical Gist Study

- Gleevec found to dramatically reduce the risk of cancer returning after surgery for Kit-positive gastrointestinal stromal tumors (GIST)

EAST HANOVER, N.J., April 12, 2007 /PRNewswire/ -- Investigators will begin offering Gleevec(R) (imatinib mesylate)* tablets to patients receiving placebo in a major North American clinical trial after an interim analysis showed participants with Kit-positive gastrointestinal stromal tumors treated with Gleevec following surgery were significantly less likely to experience a return of their cancer compared to those not taking this innovative therapy.

The interim analysis showed no recurrence of cancer in approximately 97% of patients given Gleevec for a year after surgery to remove tumors, compared to approximately 83% of those who underwent surgery but received a placebo. The investigators made these results public because the study had met its primary endpoint in terms of rate of recurrence-free survival.

The study involving more than 600 patients was sponsored by the National Cancer Institute (NCI), part of the US National Institutes of Health (NIH). It was conducted at multiple cancer centers in the US and Canada, and was led by the of Surgeons Oncology Group. Novartis supplied Gleevec for use in the study, and also provided partial funding under a Cooperative Research and Development Agreement with NCI to support the clinical development of Gleevec.

Gleevec has already been confirmed as an effective therapy in its approved use for patients with advanced metastatic or unresectable (inoperable) Kit- positive GIST. In a statement issued today by the NIH, the new findings were heralded as excellent news, with major implications for patients with primary disease.

"With these new data, we see that Gleevec may help patients with early GIST," said Diane Young, MD, Head of Global Medical Affairs at Novartis Oncology. "We will now work with the investig
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