JUNE 24, 2024

Truseltiq Has FDA Approval Withdrawn for Cholangiocarcinoma

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