28 March 2018 - Ipsen today announced that the EMA has validated the filing of a new application for an additional indication for Cabometyx for patients with previously treated advanced hepatocellular carcinoma.
The filing is based on the results of the global placebo-controlled phase 3 CELESTIAL trial which met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant improvement and clinically meaningful improvement in median OS compared with placebo in patients with advanced hepatocellular carcinoma who have been previously treated with sorafenib.