Ipsen: positive opinion on Cabometyx from CHMP

(CercleFinance.com) - Ipsen announces that the Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion on Cabomantx (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib.


The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

Ipsen says that its application for marketing authorisation is based on the results of the Celestial Phase 3 international controlled study versus placebo, which met its primary endpoint of overall survival.

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