FDA Approves HLB's Lyrfigtu (lirafugratinib) for Bile Duct Cancer

The U.S. Food and Drug Administration (FDA) has granted marketing approval for HLB's cholangiocarcinoma treatment, Lyrfigtu (lirafugratinib). The drug is indicated for adult patients with unresectable locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements who have received prior therapy. This marks the first time a Korean company has directly submitted and obtained FDA approval for a global anticancer new drug.