Cometriq (cabozantinib) filed with EMA for renal cell carcinoma- Exelixis

Exelixis has submitted a Marketing Authorization Application (MAA) for Cometriq (cabozantinib) as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to the European Medicines Agency (EMA). The EMA will now conduct its standard validation process to determine whether the submission is sufficient to permit a substantive review for marketing authorization in the European Union.

The MAA is based on results of METEOR, a phase III pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis announced top-line results from METEOR demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. These data were later presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine. The drug was filed with the FDA in December 2015.