Ipsen receives positive CHMP opinion for Cabometyx® (cabozantinib) for the second-line treatment of patients with hepatocellular carcinoma (HCC)
Paris, France, September 21st, 2018 – Ipsen (Euronext: IPN; ADR: IPSEY) 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 Medicine1.
Today’s CHMP positive opinion follows two earlier European Commission approvals for Cabometyx® in renal cell carcinoma (RCC).
1. Abou-Alfa, G, Meyer T, Cheng AL, et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med. 2018.
Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases
Ipsen delivers strong results in the first half of 2024, progresses on launches and upgrades its full-year guidance
Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor
Ipsen and Foreseen Biotechnology announce exclusive global licensing agreement for antibody-drug conjugate with first-in-class potential
Ipsen expands collaboration and license agreement for development of Cabometyx® in advanced neuroendocrine tumors based on positive CABINET Phase III trial
Ipsen’s Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis
Ipsen and Marengo Therapeutics announce second strategic partnership to advance precision T cell engagers from Marengo’s Tri-STAR platform
Ipsen appoints Josep Catllà as EVP, Chief Corporate Affairs Officer
Ipsen presents long-term elafibranor efficacy and itch-related quality of life data in patients with primary biliary cholangitis