Posted by Michael Wonder on 28 Apr 2023
CHMP issues positive opinion for futibatinib for the treatment of adults with cholangiocarcinoma
27 April 2023 - Taiho Pharmaceutical announced today that the EMA's CHMP has issued a positive opinion recommending the conditional marketing authorisation of futibatinib for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
The positive CHMP opinion on futibatinib is based on data from the pivotal Phase 2 FOENIX-CCA2 trial in 103 patients with locally advanced or metastatic unresectable intrahepatic CCA, harboring FGFR2 fusions or rearrangements who had received one or more prior lines of systemic therapy.
