Data from Pharmawand - Curated by EPG Health - Date added 16 November 2018
Exelixis announced that its partner Ipsen received approval from the European Commission (EC) for Cabometyx (cabozantinib) tablets as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. This approval allows for the marketing of Cabometyx in this indication in all 28 member states of the European Union, Norway and Iceland.
The EC approval is based on results from the CELESTIAL trial of Cabometyx in patients with advanced HCC who received prior sorafenib. In this phase III pivotal trial, Cabometyx demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo. Cabometyx is also approved in the European Union for the treatment of advanced renal cell carcinoma (RCC) in adults who have received prior VEGF-targeted therapy and for previously untreated intermediate- or poor-risk advanced RCC.
Comment: On May 29, 2018, Exelixis announced that the FDA accepted for filing the supplemental New Drug Application (sNDA) for Cabometyx for previously treated advanced HCC and assigned a Prescription Drug User Fee Act action date of January 14, 2019.