European Commission Approves Afinitor Tablets

The European Commission (EC) has approved Afinitor (everolimus) 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 EC based its approval on data from a pivotal phase 3 trial. It demonstrated that Afinitor, when compared with placebo, more than doubled the median time without tumor growth or death in patients with advanced kidney cancer, whose disease progressed following prior VEGF-targeted therapy (4.9 vs 1.9 months).

Additionally, the data showed that Afinitor reduced the risk of disease progression or death by 67%, based on the primary endpoint of progression-free survival (PFS).

David Epstein, president and CEO of Novartis Oncology, Novartis Molecular Diagnostics, said: This approval means that across Europe thousands of patients with advanced kidney cancer now have the opportunity for a clear treatment path with Afinitor if their disease progresses after treatment with a targeted therapy.