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In a single-arm trial involving 108 previously treated patients with unresectable locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements, TRUSELTIQ demonstrated its efficacy. The primary efficacy endpoints were the objective response rate (ORR) and duration of response (DoR) as assessed by an independent review committee.
The results showed that the objective response rate was 23%, including a complete response rate of 1% and a partial response rate of 22%. The median duration of response was 5.0 months, and the median time to response was 3.6 months.
FDA，2021.05
