Posted by Michael Wonder on 16 Nov 2018
European Commission approves Ipsen’s Cabometyx (cabozantinib) for the treatment of hepatocellular carcinoma in adults previously treated with sorafenib
15 November 2018 - Ipsen today announced that the European Commission has approved Cabometyx (cabozantinib) 20 mg, 40 mg, 60 mg as a monotherapy for hepatocellular carcinoma in adults who have previously been treated with sorafenib.
This approval allows for the marketing of Cabometyx (cabozantinib) in this indication in all 28 member states of the European Union, Norway and Iceland.
The approval is based on the results of the global placebo-controlled CELESTIAL phase 3 pivotal trial which met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared with placebo in patients with advanced hepatocellular carcinoma who have been previously treated with sorafenib. In July 2018, CELESTIAL phase 3 pivotal trial results were published in the New England Journal of Medicine.
