Onco-Summaries: Daily Oncology Updates at a Glance

28/08/2026

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• NMPA Approves ATLED (Fanregratinib) for FGFR2+ Intrahepatic Cholangiocarcinoma

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NMPA Approves ATLED (Fanregratinib) for FGFR2+ Intrahepatic Cholangiocarcinoma (Ref)

China’s NMPA has conditionally approved HUTCHMED's ATLED (fanregratinib, HMPL‑453), a selective FGFR1/2/3 inhibitor, for adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions/rearrangements after prior systemic therapy

The approval is supported by data from the Phase 2 registration cohort of the single-arm, multi-center, open‑label, pivotal Phase 2/3b trial of ATLED in China (NCT04353375):

• ORR: 42.5%

• Median DoR: 6.9 months

• DCR: 83.9%

• Median PFS: 6.9 months

• Median OS: 16.6 months

Phase 3b confirmatory cohort began enrollment in January 2026 to validate efficacy and safety

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