14 September 2016 - Cabometyx is the first and only therapy approved in the European Union to demonstrate improved overall survival, progression-free survival and objective response rate in a large, randomized phase 3 trial of patients with advanced kidney cancer.
Exelixis today announced that the European Commission has approved Cabometyx (cabozantinib maleate) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
Cabmometyx was granted accelerated assessment by the European Medicines Agency, and is the first therapy to demonstrate in a phase 3 trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — overall survival, progression-free survival and objective response rate. This approval allows for the marketing of Cabometyx in all 28 member states of the European Union, Norway and Iceland.