Infigratinib
[12] Infigratinib was originally developed at a higher dose for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.[4][7] The US Food and Drug Administration (FDA) approved infigratinib based on evidence from one clinical trial (NCT02150967) of 108 participants with bile duct cancer (cholangiocarcinoma).[7] The CBGJ398X2204 trial was a multicenter open-label single-arm trial that enrolled 108 participants with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement as determined by local or central testing.[7] Infigratinib has since been developed at a lower dose (0.25 mg/kg) for children with achondroplasia, a condition caused by variants in the FGFR3 gene.[7][8] Infigratinib has since been withdrawn from commercialization due to the sponsor's difficulties distributing the drug and enrolling a confirmatory clinical trial.