HUTCHMED (NASDAQ:HCM) announced Monday that the China National Medical Products Administration (NMPA) has accepted its New Drug Application for fanregratinib and granted it priority review status.
The oral therapy is designed to treat adult patients with advanced intrahepatic cholangiocarcinoma (ICC) who harbor specific genetic alterations known as FGFR2 fusions or rearrangements.
The priority designation accelerates the regulatory timeline for fanregratinib (HMPL-453), a selective inhibitor targeting fibroblast growth factor receptors (FGFR) 1, 2, and 3.
ICC is a highly aggressive malignancy of the bile ducts and is the second most common primary liver cancer after hepatocellular carcinoma.
In China, where liver cancer rates are among the highest in the world, ICC represents roughly 8.2% to 15% of cases.
Patients with ICC face a grim prognosis, with an overall five-year survival rate of approximately 9%.
For the 10% to 15% of patients whose tumors are driven by FGFR2 fusions, fanregratinib offers a precision medicine approach that specifically disrupts the signaling pathways responsible for tumor growth and survival.
The application is supported by a multi-center Phase II registration study conducted in China.