The FDA has granted regular approval to cabozantinib (Cabometyx, Exelixis) for the treatment of patients with advanced renal cell carcinoma (RCC) in the first-line setting. The agency approved cabozantinib to treat patients with advanced RCC who have received prior antiangiogenic therapy in 2016.
This expanded approval was based on data from the phase 2, multicenter, randomized, open-label CABOSUN trial of previously untreated patients with intermediate- and poor-risk RCC (ClinicalTrials.gov