The FDA granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
The FDA also approved FoundationOne CDx (Foundation Medicine) as a companion diagnostic test to select patients for treatment with infigratinib.