Elevar Wins FDA Approval for Lyrfigtu in Bile Duct Cancer, Marking a First for a Korean Company

Elevar Therapeutics has received FDA approval for Lyrfigtu (lirafugratinib), a targeted treatment for previously treated bile duct cancer, marking a significant milestone for South Korea’s pharmaceutical industry.

The U.S. Food and Drug Administration approved Lyrfigtu for patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma whose tumors harbor an FGFR2 gene fusion or other rearrangement.

According to Jin Yang-gon, chairman of HLB Group, Elevar’s parent company, Lyrfigtu is the first novel cancer drug developed by a Korean company to receive FDA approval.

The approval represents a major step for Elevar as it seeks to establish itself as a global oncology company and develop innovative medicines independently rather than relying primarily on licensing or technology-export deals.

Lyrfigtu belongs to a new generation of FGFR inhibitors and was designed to selectively target FGFR2 while limiting activity against other proteins in the FGFR family. This approach is intended to improve tolerability while maintaining anti-tumor activity.

Elevar acquired the drug from Relay Therapeutics in 2024 in a deal that included $75 million in upfront and regulatory milestone payments, with up to $425 million in potential commercial milestones.

The FDA approval was supported by data from the Phase 2 Refocus trial, a single-arm study involving 116 patients with cholangiocarcinoma who had previously received chemotherapy or chemoimmunotherapy but had not been treated with an FGFR inhibitor.

In the study, Lyrfigtu achieved an objective response rate of 46%, while the median duration of response was 11.8 months. Median progression-free survival reached 11.3 months.

The drug’s mechanism of action could also allow it to address resistance mutations that can develop following treatment with earlier FGFR inhibitors. Lyrfigtu uses an irreversible covalent-binding mechanism to provide sustained inhibition of FGFR2, including several resistance mutations.

“This FDA approval brings an important next-generation precision medicine option directly to patients with advanced bile duct cancer,” said Lipika Goyal, M.D., of Stanford Cancer Center and lead author of the Refocus trial.

Elevar expects Lyrfigtu to become available to U.S. patients before the end of 2026. The company has also submitted a marketing authorization application to the European Medicines Agency, expanding its plans for international commercialization.

Beyond bile duct cancer, Elevar is investigating Lyrfigtu in additional cancer settings, including tumor-agnostic clinical trials. The company is also exploring potential combinations with other oncology therapies.

Following the FDA approval, Elevar expects patient enrollment across its ongoing clinical programs to accelerate as it continues to evaluate the drug’s potential across a broader range of cancers.