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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

ties included anemia (17%), thrombocytopenia (17%), neutropenia (8%) and increased creatinine (8%).

In GIST, severe (NCI Grades 3/4) lab abnormalities (400 mg/day; 600 mg/day) -- including neutropenia (10%; 11%), anemia (3%; 9%), thrombocytopenia (0%; 1%) and hepatotoxicity (6%; 8%) -- and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (e.g., pleural effusion or ascites; 3%; 8%) and superficial edema (6%; 5%), hemorrhage (6%; 11%), abdominal pain (11%; 4%), nausea (6%; 4%), diarrhea (3%; 7%) and musculoskeletal pain (6%; 1%) were reported among patients receiving Gleevec.

Severe congestive heart failure and left ventricular dysfunction have occasionally been reported. Most of the patients with reported cardiac events have had other comorbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated.

Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse reactions, or hematologic adverse reactions. Therapy with Gleevec was discontinued for drug-related adverse reactions in 2.4% to 5% of adult patients with Ph+ CML and for adverse reactions in 5% of KIT+ GIST patients. None of the 5 patients in the ASM study discontinued Gleevec due to drug-related events or abnormal laboratory values. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example, every 2-3 months).

A 25% decrease in the recommended dose should be used for patients with severe hepatic impairment.

Some GIST patients (5%) were reported to have severe gastrointestinal (GI) bleeds and/or intratumoral bleeds. GI tumor sites may have been the source of GI bleeds.

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SOURCE Novartis
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