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Infigratinib is indicated for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma who have fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements, as confirmed by an FDA-approved test.
This indication was approved under the accelerated approval pathway based on the overall response rate and duration of response. Continued approval of this indication may be contingent upon the verification and description of clinical benefit in confirmatory trials.
FDA，2021.05
