Drug intelligence / Profile preview

FGF401 + spartalizumab

Development stage
Unknown
Lead developer
Novartis
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

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.

Other names
roblitinib + spartalizumabFGF401 + PDR001
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)FGFR4 (Fibroblast growth factor receptor 4)

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