Exelixis Inc. completed its submission of a supplemental new drug application to the U.S. Food and Drug Administration for Cabometyx in treating a type of liver cancer.
Cabometyx is already approved as a treatment for renal cell carcinoma, a kidney cancer, and the supplemental new drug application will help expand its indication.
The San Francisco-based biotechnology company made the regulatory submission based on results from the phase 3 Celestial study of Cabometyx, also known as cabozantinib, in patients with previously treated advanced hepatocellular carcinoma.
In March 2017, the FDA granted orphan drug designation to the treatment for the said indication.
Liver cancer is the second-leading cause of cancer deaths globally, with more than 700,000 deaths and nearly 800,000 new cases annually. Hepatocellular carcinoma is the most common form of liver cancer, making up about three-fourths of the roughly 42,000 new cases in the U.S. in 2018.
