European Commission approves Ipsen’s Cabometyx? (cabozantinib) for the treatment of hepatocellular carcinoma in adults previously treated with sorafenib

發(fā)布時(shí)間： 2018-11-16 閱讀：990次

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Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved Cabometyx? (cabozantinib) 20, 40, 60 mg 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.

The EC approval is based on the results of the global placebo-controlled CELESTIAL phase 3 pivotal trial which met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared with placebo in patients with advanced HCC who have been previously treated with sorafenib. In July 2018, CELESTIAL phase 3 pivotal trial results were published in the New England Journal of Medicine.3 

The EC has also approved Cabometyx? for the treatment of advanced renal cell carcinoma (aRCC) both in treatment-na?ve adults with intermediate or poor risk (May 2018) and in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (September 2016).

【from IPSEN】