Ipsen announces EMA validation of filing of a new application for additional indication for Cabometyx

Ipsen

28 March 2018 - Ipsen today announced that the EMA has validated the filing of a new application for an additional indication for Cabometyx for patients with previously treated advanced hepatocellular carcinoma.

The filing is based on the results of the global placebo-controlled phase 3 CELESTIAL trial which met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant improvement and clinically meaningful improvement in median OS compared with placebo in patients with advanced hepatocellular carcinoma who have been previously treated with sorafenib.

Read Ipsen press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , Europe , Dossier