Ipsen's Cabometyx gains European approval in hepatocellular carcinoma

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. It adds to the drug’s existing European approvals, which include the treatment of advanced renal cell carcinoma (aRCC) both in treatment-naïve adults with intermediate or poor risk and following prior vascular endothelial growth factor (VEGF)-targeted therapy. 

"Today’s EC approval for the use of Cabometyx provides a much needed new option for HCC patients. Until now, physicians in Europe had only one approved therapy for the 2nd line treatment of this aggressive and difficult-to-treat cancer," commented Harout Semerjian, Chief Commercial Officer at Ipsen. "We are proud to offer Cabometyx as an innovative treatment that has been shown to extend survival in previously treated patients with HCC. This new indication reinforces Ipsen’s commitment to improve patients’ lives through the expansion of the clinical benefit of Cabometyx in the treatment of solid tumours."

Professor Philippe Merle, Hepatology and Gastroenterology Specialist at La Croix-Rousse Hospital in Lyon, added: "Patients with HCC in Europe can now benefit from a treatment that has, through the CELESTIAL trial, proven effective in prolonging life and delaying disease progression. This is a very encouraging development for liver cancer patients, and provides physicians with a new therapeutic option for this complex disease."

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