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FDA Approves Gleevec For Expanded Use in Patients With Rare Gastrointestinal Cancer
Date:1/31/2012

SILVER SPRING, Md., Jan. 31, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today's action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

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Gleevec was originally granted accelerated approval for the treatment of advanced or metastatic GIST in 2002. In 2008 Gleevec received a subsequent accelerated approval for adjuvant use that is for the treatment of patients with GIST who had had potentially curative resection (surgical removal) of GIST tumors, but who were at increased risk for a recurrence. The accelerated approval program provides earlier patient access to promising new drugs while the confirmatory clinical trials are being conducted. Regular approval for the metastatic GIST indication was also granted in 2008.

GIST is a rare form of cancer that originates in cells found in the wall of the GI tract. These cells, known as interstitial cells of Cajal, are part of the autonomic nervous system, which regulates body processes such as food digestion. More than half of GISTs start in the stomach.

"The development of Gleevec over the past decade highlights the need to further study drugs after approval to truly characterize their benefits," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Although originally approved in the metastatic disease setting, this subsequent trial has demonstrated that longer use of Gleevec can prolong patient's lives in earlier disease settings."

The label is being updated to include clinical data from a large randomize
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SOURCE U.S. Food and Drug Administration
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