Ipsen’s Cabometyx has received approval from the European Commission for Cabometyx (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma (HCC) when sorafenib has already been used, it has emerged.
The ruling, which will allow the medication to be marketed in the aforementioned indication across all 28 European member states, was based on Phase 3 data in which Cabometyx demonstrated a “statistically significant and clinically meaningful” boost to overall survival compared to placebo.