HUTCHMED (Nasdaq/AIM: HCM) announced that the New Drug Application for fanregratinib (HMPL-453) in second-line intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion/rearrangement has been accepted and granted priority review by the China NMPA on Dec 29, 2025. Fanregratinib is an oral selective FGFR 1/2/3 inhibitor.
The NDA is supported by a single-arm, multi-center Phase II registration study in China (clinicaltrials.gov identifier NCT04353375) that met its primary endpoint of objective response rate; secondary endpoints (PFS, DCR, DoR, OS) also supported the primary findings. ICC accounts for roughly 8.2–15.0% of primary liver cancers and has an approximate 5-year overall survival of 9%; ~10–15% of ICC tumors harbor FGFR2 fusions/rearrangements.
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