( ve GIST. In a statement issued today by...)Positive Results Prompt US National Cancer Institute to Make Glivec,Available to Patients in Post-Surgical GIST Study,Health

"With these new data, we see that Glivec may help patients with early GIST," said Diane Young, MD, Head of Global Medical Affairs at Novartis Oncology. "We will now work with the investigators on a submission to gain regulatory approval for Glivec as adjuvant treatment for GIST."

Following the recommendation of a data monitoring committee, the study will be closed and patients in the study who are currently being treated with placebo may choose to receive one year of Glivec.

In the study, patients were randomized to one of two treatment arms. Neither the patients nor physicians knew which treatment the patients were receiving. One patient group received Glivec at a dose of 400 mg per day for one year, while the second group received placebo for one year. According to the study design, patients who developed a recurrence of their cancer while on a study therapy were unblinded to their treatment assignment. Those receiving placebo subsequently received Glivec, while those already given Glivec continued with this therapy but at a higher dose. Study results will be presented at a forthcoming scientific meeting.

Gastrointestinal stromal tumors (GIST) belong to a group of cancers known as soft tissue sarcomas that usually arise from the intestinal tract, with the most common site being the stomach and followed by the small intestine. The incidence of GIST is estimated to be 4,500-6,000 new cases per year in the US (15-20 cases per million population), of which more than 90% are Kit-positive.

Investigators in the NCI study reported that Glivec therapy was well tolerated by most patients, with side effects similar to those observed in other clinical trials with Glivec. These include nausea, diarrhea and swelling (edema). Information on more than 600 patients enrolled in the study was
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