HUTCHMED (China) announced that the New Drug Application (NDA) for fanregratinib (HMPL-453) for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (ICC) with Fibroblast Growth Factor Receptor (FGFR) 2 fusion/rearrangement who have previously received systemic therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA).

Fanregratinib (HMPL?453) is a novel, selective, oral inhibitor targeting FGFR 1/2/3. ICC is a highly aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for 8.2-15.0 percent of primary liver cancers, and consequently, it is the second most common type after hepatocellular carcinoma. In recent years, the incidence of ICC has continued to rise, with a five-year overall survival rate of approximately nine percent. Approximately, 10-15 percent of ICC patients globally have tumours harbouring FGFR2 fusions or rearrangements.

This NDA is supported by data from a single-arm, multi-centre, open-label, phase II registration study in China. The study has met its primary endpoint of Objective Response Rate (ORR). Results from the secondary endpoints including Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR) and Overall Survival (OS) also support the primary endpoint findings.

Full results will be submitted for presentation at an upcoming scientific conference.