The European Commission granted approval to Novartis’ Afinitor® (everolimus) as a treatment for advanced renal cell carcinoma (RCC) in patients whose disease has progressed despite VEGF-targeting therapies. EC approval follows FDA green light of Afinitor in March for treating patients with advanced RCC who had failed Sutent® (Pfizer) or Nexavar® (Bayer Healthcare and Onyx Pharmaceuticals).
FDA previously approved the drug for treating RCC after the failure of VEGF-targeting therapy. Afinitor is also under review by regulatory authorities in Switzerland, Japan, and other countries.
Novartis is investigating Afinitor in multiple cancer types including neuroendocrine, breast, gastric, and hepatocellular carcinomas as well as against tuberous sclerosis complex and non-Hodgkin’s lymphoma. The company says that it completed 14 major submissions for the drug in the U.S., Europe, and Japan during 2008.
Everolimus was first approved in the EU in 2003 under the trade name Certican for the prevention of organ rejection in heart and kidney transplant patients. Certican is not approved in the U.S., however.