The FDA on May 28, 2021, granted accelerated approval to TRUSELTIQ®, a kinase inhibitor, for adults with previously treated, unresectable locally advanced or metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) fusion or other rearrangement, as detected by an FDA-approved test. TRUSELTIQ® is a product of QED Therapeutics, Inc.
The FDA also approved FoundationOne® CDx (Foundation Medicine, Inc.) for selection of patients with FGFR2 fusion or other rearrangement as a companion diagnostic device for treatment with TRUSELTIQ®.
