HLB Wins FDA Approval for Bile Duct Cancer Drug Lyrfigtu

South Korean biopharmaceutical company HLB said its U.S. subsidiary Elevar Therapeutics has received approval from the U.S. Food and Drug Administration for Lyrfigtu, a targeted treatment for certain patients with bile duct cancer.

The drug, known generically as lirafugratinib, was approved for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma whose tumors carry an FGFR2 gene fusion or another rearrangement. Cholangiocarcinoma is a rare cancer arising in the bile ducts, the channels that carry bile from the liver.

Lyrfigtu is an oral kinase inhibitor designed to selectively target FGFR2. The FDA evaluated the drug in a multicenter, open-label study involving 116 patients who had received previous chemotherapy or chemoimmunotherapy and had not been treated with an FGFR inhibitor. The study recorded an objective response rate of 46 percent, while the median duration of response was 11.8 months.

Elevar expects to make the medicine available in the United States during the fourth quarter of 2026. HLB said the approval represents the first case in which a South Korean pharmaceutical or biotechnology company directly submitted a new drug application for an anticancer medicine and secured FDA authorization.

The approval gives HLB a commercial foothold in the U.S. oncology market after the group built its own development and regulatory capabilities rather than licensing the asset to a larger pharmaceutical company. HLB Chairman Jin Yang-gon said the company had accumulated experience comparable to that of major global drugmakers during the review process and expects patent protection for Lyrfigtu through 2040.

HLB is also seeking to broaden the drug's geographic reach and potential uses. Elevar applied this month for marketing authorization from the European Medicines Agency and is studying lirafugratinib in other solid tumors with FGFR2 fusions or rearrangements. The company has said it will work to supply the treatment to physicians and patients as quickly as possible.

The FDA granted the application priority review and had previously given lirafugratinib breakthrough therapy and orphan drug designations. The prescribing information warns of risks including ocular toxicity, elevated phosphate levels, soft-tissue mineralization and harm to a fetus.

HLB plans to use the regulatory infrastructure developed for Lyrfigtu as it advances other medicines. Jin said preparations are continuing to resubmit an FDA application for the liver cancer drug rivoceranib after addressing manufacturing issues raised during earlier reviews. The group also expects clinical readouts from other subsidiaries later this year.