Cabozantinib for HCC in adultsJanuary 14, 2019
Ipsen received approval from the European Commission (EC) for cabozantinib (Cabometyx) tablets as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
The EC approval is based on results from the CELESTIAL trial of cabozantinib in patients with advanced HCC who received prior sorafenib. In this phase 3 pivotal trial, cabozantinib demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo.
The drug is also approved in the EU 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.
Ipsen is a partner of Exelixis, Inc.