The FDA has announced the final withdrawal of its approval of infigratinib (Truseltiq, QED Therapeutics) 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.
The accelerated approval of infigratinib required the sponsor to conduct postmarketing trials to verify the clinical benefit of the drug. The sponsor voluntarily requested