Therapeutic Response

FGFR2::v status confers therapeutic sensitivity to Infigratinib in patients with Cholangiocarcinoma.

Statements

Source and description

Truseltiq (infigratinib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to infigratinib for the treatment of adult patients 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 product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).