Cholangiocarcinoma Drug Withdrawn from Market

Late last week, the FDA withdrew accelerated approval of infigratinib (Truseltiq; Helsinn), which was granted in 2021 for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement. At that time, Helsinn agreed to conduct additional research to verify the drug’s clinical benefit. However, the company struggled to recruit patients for a confirmatory trial of infigratinib in first-line cholangiocarcinoma, a new indication under investigation, and determined that continuing to study and market the drug as a second-line therapy was not commercially feasible.