The U.S. Food and Drug Administration (FDA) has accepted for filing Exelixis’ (EXEL) supplemental New Drug Application (sNDA) for Cabometyx® (cabozantinib) tablets for patients with previously treated advanced hepatocellular carcinoma (HCC). The FDA has determined that the application is sufficiently complete to permit a substantive review.
The filing has been assigned a Prescription Drug User Fee Act (PDUFA) action date of January 14, 2019.
Commenting on the news, Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis stated, “Patients with this aggressive form of advanced . . .