Exelixis has submitted a supplemental New Drug Application to the Food and Drug Administration for cabozantinib (Cabometyx) for the treatment of previously untreated advanced renal cell carcinoma (RCC).
The application, announced on Aug. 16, seeks to allow the manufacturer to modify the label. Cabozantinib was approved in April 2016 for treatment of patients with advanced RCC who had previously received antiangiogenic therapy.
The results of the trial were published in the Journal of Clinical Oncology (2017 Feb 20;35[6]:591-7). An independent review committee confirmed the primary efficacy endpoint results in June 2017.