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Priority Review Granted for Cabozantinib in Previously Untreated Advanced Kidney Cancer

By: Sarah Jackson
Posted: Wednesday, October 18, 2017

The U.S. Food and Drug Administration (FDA) granted a Priority Review for cabozantinib (Cabometyx) for use in previously untreated patients with advanced renal cell carcinoma, as outlined in a press release by Exelixis on October 16, 2017. The supplemental New Drug Application for cabozantinib was based on the results of the randomized phase II CABOSUN trial, which was first presented at the European Society for Medical Oncology (ESMO) 2016 Congress and was updated at the ESMO 2017 Congress. The study findings were also published in the Journal of Clinical Oncology.

A total of 157 patients with advanced renal cell carcinoma were enrolled in the CABOSUN trial. They were randomized to receive either cabozantinib or sunitinib. A blinded independent radiology review committee confirmed that cabozantinib provided a clinically meaningful and statistically significant improvement in the primary efficacy endpoint of investigator-assessed progression-free survival. The results of this review were presented at the ESMO 2017 Congress.

Cabozantinib was previously approved by the FDA for the treatment of patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy. In August 2017, cabozantinib was approved as an initial treatment of advanced renal cell carcinoma in the European Union.