China Approves New Drug for Advanced Cholangiocarcinoma

China's National Medical Products Administration (NMPA) has granted conditional approval for HUTCHMED's fanregratinib (ATLED®). This novel, selective, oral inhibitor targets FGFR 1/2/3 and is approved for adults with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion or rearrangement, following prior systemic therapy. The approval is based on Phase II trial data showing a 42.5% objective response rate, offering a new treatment option for this challenging cancer.