Who can use Truseltiq(Infigratinib)?

This medication is indicated for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

Approved Use

TRUSELTIQ is approved for the treatment of adults diagnosed with unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) whose tumors have a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement as detected by an FDA-approved companion diagnostic test. This indication falls under the FDA's accelerated approval pathway, which was granted based on the observed overall response rate and duration of response in clinical studies. Patients must have received at least one prior line of systemic therapy.