The FDA approved Elevar Therapeutics’ Lyrfigtu (lirafugratinib) on September 23, 2026, for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma—bile duct cancer—whose tumors have an FGFR2 fusion or other rearrangement.
Lyrfigtu is an oral FGFR2 kinase inhibitor. The decision supports use after prior treatment, rather than for all bile duct cancer patients; tumor genomic testing is needed to identify the eligible FGFR2-altered group.
The approval was based on the Phase 1/2 ReFocus trial. In the relevant population, the confirmed objective response rate was about 46%, median duration of response was 11.8 months, and median progression-free survival was 11.3 months.
Elevar is majority-owned by South Korea’s HLB Co. The approval has been described as the first time a South Korean company directly filed for and obtained FDA approval for a novel cancer drug.
Elevar said it expects U.S. availability in the fourth quarter of 2026. The FDA had previously granted the application Priority Review; the drug also received Breakthrough Therapy and orphan-drug designations.
Sources:
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