European Commission approves Ipsen's Cabometyx for kidney cancer

French drugmaker Ipsen (Euronext: IPN) revealed today that the European Commission has approved Cabometyx (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.

Cabometyx is the only single agent to demonstrate significant clinical benefits across all three efficacy endpoints (OS, PFS, ORR) in a Phase III study in previously treated patients with RCC. This approval allows for the marketing of Cabometyx) in previously treated advanced RCC in all 28 member states of the European Union, Norway and Iceland.

“The approval of Cabometyx (cabozantinib) in Europe provides a breakthrough treatment to physicians and their patients suffering from renal cancer who failed on initial therapy. This oral drug has the potential to become a new standard of care in the second line setting of advanced renal cell carcinoma as it prolongs survival, slows disease progression, and shrinks tumors, with a clinically-acceptable safety and tolerability profile,” commented Ipsen chief executive David Meek.