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Exelixis' Cabometyx wins US FDA approval to treat certain liver cancer patients

The U.S. Food and Drug Administration approved Exelixis Inc.'s Cabometyx to treat certain liver cancer patients.

Cabometyx, or cabozantinib, is now approved to treat patients with hepatocellular carcinoma — the most common form of liver cancer — who have been previously treated with sorafenib, which is sold by Bayer AG as Nexavar.

Liver cancer is a leading cause of cancer death worldwide and accounts for more than 700,000 deaths and 800,000 new cases each year, with hepatocellular carcinoma making up about three-fourths of the estimated 42,000 new cases of liver cancer in the U.S. in 2019, according to Exelixis' Jan. 14 news release.

The FDA's approval is based on data from a phase 3 study called Celestial, which showed that the treatment worked better than placebo in patients with advanced hepatocellular carcinoma in improving overall survival and the length of time patients remained disease-free.

Exelixis and its partner Ipsen SA started a phase 3 trial named Cosmic-312 in December 2018 to test a combination of Cabometyx and Roche Holding AG's Tecentriq, or atezolizumab, against Nexavar in previously untreated advanced hepatocellular carcinoma. The study will also test the effectiveness of just Cabometyx as an initial therapy.

Cabometyx was approved by the European Commission in November 2018 as a monotherapy for hepatocellular carcinoma in adults who have previously been treated with Nexavar.