Hutchmed announces positive CHMP opinion for fruquintinib

HUTCHMED (HCM) announces that its partner Takeda (TAK) received notification that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer.The European Commission will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for metastatic CRC throughout the European Union, Norway, Liechtenstein and Iceland. If approved, fruquintinib will be the first and only selective inhibitor of all three vascular endothelial growth factor receptors approved in the EU for previously treated metastatic CRC. Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. The CHMP’s positive opinion was primarily based on results from the Phase III multi-regional FRESCO-2 trial, which supported the Marketing Authorisation Application. The MAA was validated and accepted for review by the EMA in June 2023.