BRIEF—New EU indication for Cabometyx

The European Commission has approved an additonal indication for French drugmaker Ipsen’s Cabometyx (cabozantinib) as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.

This approval allows for the marketing of Cabometyx (cabozantinib) in this indication in all 28 member states of the European Union, Norway and Iceland.

“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. We are proud to offer Cabometyx as an innovative treatment that has been shown to extend survival in previously treated patients with HCC,”said Ipsen’s chief commercial officer Harout Semerjian.

“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 tumors,” he added.

In February of 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the USA, Canada and Japan. This agreement was amended in December of 2016 to include commercialization rights for Ipsen in Canada.