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Gleevec Given Priority FDA Review for Intestinal Cancer 2008.09.01

The U.S. Food and Drug Administration has given priority review to the Novartis drug Gleevec (imatinib mesylate) as a treatment for gastrointestinal cancer after surgery, the Associated Press reported Wednesday.
Priority review means the agency is likely to decide whether to approve Gleevec for gastrointestinal stromal tumors within six months, instead of the typical 10 months. The drug is already approved to treat other types of cancer.
Novartis said in clinical testing, people with kit-positive gastrointestinal cancer who got Gleevec lived longer and were 89 percent less likely to have the cancer return than those who didn't take the drug, the wire service reported.
A protein mutation that characterizes kit-positive forms of this cancer is present in more than 90 percent of cases in the United States, the AP said.


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