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| |  EU Approves Everolimus for Second-Line Treatment of Advanced Kidney Cancer NEW YORK -- August 6, 2009 -- The European Commission has approved everolimus (Afinitor) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. The approval is based on data from a phase 3 trial demonstrating that everolimus, when compared with placebo, more than doubled the median time without tumour growth or death in patients with advanced kidney cancer whose disease progressed following prior VEGF-targeted therapy (4.9 vs 1.9 months). Everolimus reduced the risk of disease progression or death by 67% based on the primary endpoint of progression-free survival (PFS) (hazard ratio = 0.33; 95% confidence interval 0.25-0.43; P < .0001) The most common adverse drug reactions include stomatitis, rash, fatigue, asthenia, diarrhoea, anorexia, nausea, mucosal inflammation, vomiting, cough, infections, peripheral oedema, pneumonitis, epistaxis, dry skin, pruritus, dyspnoea and abnormal taste, as well as decreased haemoglobin, lymphocytes, phosphate, platelets, neutrophils, and increased cholesterol, triglycerides, glucose, creatinine, aspartate aminotransferase, and alanine aminotransferase. The most frequent grade 3/4 adverse reactions were lymphocytes decreased, glucose increased, haemoglobin decreased, phosphate decreased, cholesterol increased, infections, stomatitis, fatigue, and pneumonitis. SOURCE: Novartis
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