Hutchmed Gets Conditional Approval for Cholangiocarcinoma Treatment ATLED

HUTCHMED has secured conditional approval from China's National Medical Products Administration for its oral FGFR inhibitor, ATLED (fanregratinib, HMPL-453), to treat advanced intrahepatic cholangiocarcinoma.

The treatment is intended for patients with FGFR2 fusion or rearrangement-positive intrahepatic cholangiocarcinoma who have received prior systemic therapy.

The Phase II registration cohort reported an objective response rate of 42.5% and median progression-free survival of 6.9 months, with a disease control rate of 83.9% and median overall survival of 16.6 months.