The treatment is a first for nearly 40% of all RCC patients whose disease progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.
Approval was based on data from Phase III trials, which showed that Afinitor, when compared with placebo, more than doubled the median time without tumour growth or death in patients with advanced kidney cancer.
The trial also showed that Afinitor reduced the risk of disease progression or death by 67% based on the primary endpoint of progression-free survival.
Novartis Oncology, Novartis Molecular Diagnostics president and CEO David Epstein 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.”
The EC decision applies in all 27 EU member states. Afinitor is still under regulatory review in Switzerland, Japan and other countries.