[KHIDI USA C&D Success | HLB] HLB’s First U.S. New Drug Approval · FDA Approval of Lyrfigtu (Elevar Therapeutics) for FGFR2-Altered Cholangiocarcinoma #KHIDI USA C&D Comapany

The U.S. FDA has approved Lyrfigtu (lirafugratinib), an FGFR2-selective inhibitor developed by HLB’s U.S. subsidiary, Elevar Therapeutics, as a second-line treatment for cholangiocarcinoma with FGFR2 fusions or rearrangements. The approval was based on the ReFocus clinical trial, which demonstrated an objective response rate (ORR) of approximately 46%.

This marks HLB’s first U.S. new drug approval, following three Complete Response Letters (CRLs) for its liver cancer combination therapy of rivoceranib and camrelizumab. The company plans to launch Lyrfigtu in the U.S. in the fourth quarter and leverage the commercial infrastructure established for the launch to support its subsequent liver cancer therapy. https://endpoints.news/elevar-wins-first-fda-approval-with-second-line-bile-duct-cancer-drug/