FDA grants Priority Review for Exelixis’s CABOMETYX to treat advanced RCC

Exelixis announced that the U.S. Food and Drug Administration (FDA) has determined the company’s supplemental New Drug Application (sNDA) for CABOMETYX^®(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 (PDUFA) action date of February 15, 2018.

“The acceptance of the sNDA filing with a Priority Review is an important regulatory milestone for CABOMETYX and for our mission to improve treatment outcomes for patients with cancer,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We look forward to working with the FDA as they review the application in our effort to offer CABOMETYX to patients with previously untreated metastatic RCC who are in need of new treatment options.”

The sNDA is based on data from CABOSUN, a randomized phase 2 trial conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP).

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. CABOMETYX 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 3 METEOR trial, which demonstrated that CABOMETYX provided a statistically significant and clinically meaningful improvement in overall survival, progression-free survival (PFS), and objective response rate as compared with everolimus in this patient population.