FGFR2 fusions define a targetable subset of cholangiocarcinoma, and several inhibitors reached the market in quick succession. Truseltiq (infigratinib) was the one that did not survive commercially.
Infigratinib was an oral FGFR inhibitor blocking the growth signaling that drives these bile duct tumors. Its accelerated approval covered previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement.
The FDA withdrew its approval in May 2024 at the sponsor’s request, which cited difficulty enrolling the required confirmatory first-line trial and the conclusion that continued distribution was no longer commercially reasonable. It illustrates how quickly a narrow oncology niche can become commercially unviable.
