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FGF401 + spartalizumab is an investigational **combination therapy** consisting of FGF401 (roblitinib), a potent and selective inhibitor of fibroblast growth factor receptor 4 (FGFR4), and spartalizumab (PDR001), a humanized monoclonal antibody that targets PD-1. The combination is being studied primarily in patients with **hepatocellular carcinoma (HCC)** and other solid tumors exhibiting **FGFR4/KLB** expression. FGF401 blocks the FGF19-FGFR4 pathway that drives tumor growth and survival in some cancers, while spartalizumab acts as an **immune checkpoint inhibitor** by preventing PD-1 interaction with its ligands (PD-L1, PD-L2), thereby promoting T-cell-mediated anticancer activity.
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