Posted by Michael Wonder on 24 Sep 2018
Ipsen receives positive CHMP opinion for Cabometyx (cabozantinib) for the second-line treatment of patients with hepatocellular carcinoma
21 September 2018 - Ipsen announced today that the CHMP, the scientific committee of the EMA), provided a positive opinion for Cabometyx (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma in adults who have been previously treated with sorafenib.
The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
The EMA 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 and clinically meaningful improvement in OS compared with placebo in patients with advanced HCC 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.
