Cometriq (cabozantinib) filed with FDA in rolling submission for renal cell carcinoma- Exelixis

Exelixis has completed the submission of its rolling New Drug Application (NDA) with the FDA for Cometriq (cabozantinib) as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Exelixis has requested Priority Review as part of the NDA filing.

The NDA submission 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 presented at the European Cancer Congress in September 2015 and published in The New England Journal of Medicine.

In the European Union, Exelixis aims to complete its Marketing Authorization Application in early 2016. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently granted accelerated assessment to cabozantinib for advanced RCC. As a result, when filed, the company’s MAA may be eligible for a 150-day review, versus the standard 210 days.