Ipsen announces EMA validation of filing of a new application for additional indication for Cabometyx®, for patients with previously treated advanced Hepatocellular Carcinoma (HCC).
Paris, France, March 28th 2018 — Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Medicines Agency (EMA), the European regulatory authority, has validated the filing of a new application for an additional indication for Cabometyx®, for patients with previously treated advanced Hepatocellular Carcinoma (HCC).
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.
Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen, said:
“This milestone is an important step forward for the cabozantinib ongoing development program
across solid tumors, with the potential, if approved, to provide patients with advanced HCC – which is still an unmet medical need – with a new oral systemic treatment.”