The FDA has determined the supplemental New Drug Application (sNDA) for cabozantinib for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted Priority Review of the filing and assigned a Prescription Drug User Fee Act action date of Feb. 15, 2018.
The sNDA is based on data from CABOSUN, a randomized phase II trial conducted by the Alliance for Clinical Trials in Oncology as part of a collaboration with the NCI Cancer Therapy Evaluation Program.
An sNDA is an application to the FDA that, if approved, will allow a drug sponsor to make changes to a previously approved product label, including modifications to the indication. Cabozantinib was previously approved by the FDA on April 25, 2016, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. The approval was based on results from the phase III METEOR trial, which demonstrated that cabozantinib provided a statistically significant and clinically meaningful improvement in overall survival, progression-free survival, and objective response rate as compared with everolimus in this patient population.