NEJM publishes results of CELESTIAL trial of Cabometyx in patients with previously treated advanced hepatocellular carcinoma.- Ipsen + Exelixis.

Ipsen announced that The New England Journal of Medicine (NEJM) published results from the CELESTIAL phase III pivotal trial of cabozantinib in patients with previously treated advanced hepatocellular carcinoma (HCC). The data, originally presented at the 2018 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO-GI) in January and reported earlier, demonstrate that cabozantinib provided a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo.

Ipsen received validation by the European Medicines Agency in March 2018 for its application for variation to the Cabometyx marketing authorization to include the new indication for patients with previously treated advanced HCC. Ipsen’s partner Exelixis announced in May 2018 that the FDA accepted the company’s supplemental New Drug Application (sNDA) for Cabometyx (cabozantinib) tablets as a treatment for patients with previously treated HCC. The filing has been assigned a Prescription Drug User Fee Act action date of January 14, 2019.