HUTCHMED receives China approval for cholangiocarcinoma drug

HUTCHMED (China) Limited received conditional approval from China’s National Medical Products Administration for fanregratinib, marketed as ATLED, to treat adult patients with advanced intrahepatic cholangiocarcinoma and FGFR2 fusion or rearrangement. The approval, based on a Phase II trial, showed a 42.5% objective response rate and a median progression-free survival of 6.9 months.

ATLED is an oral selective inhibitor targeting FGFR 1/2/3, and the approval unlocks a new treatment option for a substantial population of pretreated advanced ICC patients with FGFR2 fusions or rearrangements.

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