Posted by Michael Wonder on 17 Aug 2017
Exelixis submits U.S. supplemental new drug application for Cabometyx (cabozantinib) for the treatment of previously untreated advanced kidney cancer
16 August 2017 - Cabometyx is the first therapy to demonstrate a clinically meaningful and statistically significant progression-free survival benefit over the current standard of care.
Exelixis today announced it has completed the submission of a supplemental new drug application to the U.S. FDA for Cabometyx (cabozantinib) tablets as a treatment for patients with previously untreated advanced renal cell carcinoma (RCC).
The sNDA submission is based on results from the CABOSUN randomised phase 2 trial of Cabometyx in patients with previously untreated advanced RCC with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium.
