Cometriq cabozantinib regulatory update

FDA granted breakthrough therapy designation to Exelixis’ Cometriq cabozantinib to treat patients with advanced renal cell carcinoma (RCC) who have received 1 prior therapy. The company plans to complete a regulatory submission for the product by year end in advanced RCC. The designation is based on data from the Phase III METEOR trial comparing Cometriq vs. Afinitor everolimus in RCC patients who progressed following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI) (see BioCentury, July 27). ...