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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

section, or removal of their tumors. Of those who have the surgery, about half will suffer a recurrence(4). 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.

Filing data

The study on which the regulatory filing is based compared the recurrence-free survival of GIST patients taking Gleevec 400 mg/day versus placebo for one year immediately following surgery. The results showed that 98% of patients receiving Gleevec remained recurrence free at one year following surgery compared to approximately 82% of those receiving placebo(3). This shows that as a result of adjuvant therapy with Gleevec, there was an 89% reduction in risk of GIST returning(2).

The study, known as ACOSOG Z90001, was conducted at multiple cancer centers throughout the US and Canada, under a Cooperative Research and Development Agreement between Novart
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SOURCE Novartis
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