Therapeutic Response

FGFR2 rearrangements status confers therapeutic sensitivity to Pemigatinib in patients with Cholangiocarcinoma.

Statements

Source and description

Pemazyre (pemigatinib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to pemigatinib 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 states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).