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Pivotal Phase III Trial of Novartis Drug Afinitor® Met Primary Endpoint in Study of Patients With Advanced Pancreatic Neuroendocrine Tumors
Date:6/2/2010

or. Oral ulceration is a common side effect of Afinitor. Renal function, blood glucose, lipids and hematological parameters should be evaluated prior to the start of therapy with Afinitor and periodically thereafter. Strong or moderate CYP3A4 or P-glycoprotein inhibitors should be avoided. An increase in the dose of Afinitor is recommended when co-administered with a strong CYP3A4 inducer.  Live vaccinations and close contact with those who have received live vaccines should be avoided by patients taking Afinitor. Afinitor should not be used in patients with severe hepatic impairment. Afinitor may cause fetal harm in pregnant women.

The most common adverse reactions, irrespective of causality (incidence greater than or equal to 30%), were stomatitis (44%), infections (37%), asthenia (33%), fatigue (31%), cough (30%) and diarrhea (30%). The most common grade 3/4 adverse reactions, irrespective of causality (incidence greater than or equal to 3%), were infections (9%), dyspnea (8%), fatigue (5%), stomatitis (4%), dehydration (4%), pneumonitis (4%), abdominal pain (3%) and asthenia (3%). The most common laboratory abnormalities (incidence greater than or equal to 50%) were anemia (92%), hypercholesterolemia (77%), hypertriglyceridemia (73%), hyperglycemia (57%), lymphopenia (51%) and increased creatinine (50%). The most common grade 3/4 laboratory abnormalities (incidence greater than or equal to 3%) were lymphopenia (18%), hyperglycemia (16%), anemia (13%), hypophosphatemia (6%) and hypercholesterolemia (4%). Deaths due to acute respiratory failure (0.7%), infection (0.7%) and acute renal failure (0.4%) were observed in patients receiving Afinitor.

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SOURCE Novartis Pharmaceuticals Corporation
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