Posted by Michael Wonder on 30 May 2018
Exelixis announces U.S. FDA accepts supplemental new drug application for Cabometyx (cabozantinib) in previously treated advanced hepatocellular carcinoma
30 May 2018 - US FDA assigns Prescription Drug User Fee Act action date of 14 January 2019.
May 29, 2018-- Exelixis today announced that the U.S. FDA has accepted for filing the company’s supplemental New Drug Application (sNDA) for Cabometyx (cabozantinib) tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC). The FDA has completed its filing review and has determined that the application is sufficiently complete to permit a substantive review.
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. Exelixis announced they submitted the sNDA for the treatment of previously treated advanced HCC to the FDA in March 2018 based on results from the CELESTIAL phase 3 pivotal trial of Cabometyx in patients with advanced HCC who received prior sorafenib.
