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FDA approves Novartis drug Gleevec® label recommending extending treatment to three years for certain GIST patients after surgery
Date:2/1/2012

r treatment period in the 36-month group and 13% in the 12-month group(1).

Novartis provided the study drug and supported the study financially. Additional funding was received from the Academy of Finland, Cancer Society of Finland, Sigrid Juselius Foundation and Helsinki University Research Funds.

About Gleevec
Gleevec® (imatinib mesylate) tablets are indicated for the treatment of patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) that are cancerous, cannot be surgically removed, and/or have spread to other parts of the body. Gleevec is also approved for use after surgery in patients that have had their KIT (CD117)-positive GIST completely removed.

Gleevec Important Safety Information
Gleevec can cause fetal harm when administered to a pregnant woman. Women taking Gleevec should not become pregnant, and should be advised of the potential risk to the unborn child.

Gleevec is often associated with edema (swelling) and serious fluid retention. Studies have shown that edema (swelling) tended to occur more often among patients who are 65 and older or those taking higher doses of Gleevec.

Cytopenias (reduction or lack of certain cell elements in blood circulation), such as anemia, have occurred. If the cytopenia is severe, your doctor may reduce your dose or temporarily stop your treatment with Gleevec.

Severe congestive heart failure and left ventricle dysfunction have been reported, particularly in patients with other health issues and risk factors. Patients with heart disease or risk factors or history of renal failure will be monitored and treated for the condition.

Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of Gleevec.

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in
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