Futibatinib is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least 1 line of systemic treatment in adults. Futibatinib is only recommended if the company provides it according to the commercial arrangement.
Why the committee made this recommendation
Usual treatment for locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement that has progressed after systemic treatment is pemigatinib. Futibatinib would be an alternative option to pemigatinib.
There are no clinical trials directly comparing futibatinib with pemigatinib. An indirect comparison of futibatinib and pemigatinib suggests that they may have similar effectiveness, but this is uncertain.
A cost comparison suggests that futibatinib has similar costs to pemigatinib. So, futibatinib is recommended.