The European Medicines Agency (EMA) has approved Cabometyx (cabozantinib) as a second-line treatment option for patients with advanced renal cell carcinoma (RCC) who have previously been treated with vascular endothelial growth factor (VEGF)-targeted therapy.

Cabozantinib is manufactured by Exelixis and Ipsen, and was given an accelerated assessment by the EMA. According to the manufacturers, cabozantinib is the first drug to show “robust and clinically meaningful improvements in all three key efficacy parameters – overall survival (OS), progression-free survival (PFS) and objective response rate (ORR),” in a phase III clinical trial, the METEOR study. In this study, cabozantinib met its primary endpoint by significantly improving PFS, and was associated with a 42% reduction in the rate of disease progression or death compared with everolimus. Cabozantinib showed a median PFS of 7.4 months versus 3.8 months for everolimus and also significantly improved the objective response rate (24% versus 4% for everolimus).

Read the Pharma Times article and the Market Watch article for more information.