Ipsen announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), provided a positive opinion for Cabometyx® (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
Alexandre Lebeaut, MD, Executive Vice President, R&D and Chief Scientific Officer, Ipsen, said:
The global burden of liver cancer is increasing and despite the recent introduction of new agents, it remains the second leading cause of cancer mortality worldwide. Following today's positive CHMP opinion and if approved by the European Commission, Cabometyx® as monotherapy will give patients with HCC a much-needed new oral therapeutic option."
Dr Lorenza Rimassa, Medical Oncology Unit, Humanitas Cancer Center, Milan, said:
The medical community is pleased that the CHMP has given a positive opinion to Cabometyx® for previously-treated patients with hepatocellular carcinoma. The fact that Cabometyx® demonstrated clinically significant benefits in both overall survival and progression-free survival in the phase 3 CELESTIAL study confirms the value it brings to this difficult treatment landscape."
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.
Today's CHMP positive opinion follows two earlier European Commission approvals for Cabometyx® in renal cell carcinoma (RCC).