HLB says bile duct cancer drug lirafugratinib enters full review for European approval

Oct 07, 2026, 04:35 pm

HLB's novel cholangiocarcinoma treatment, lirafugratinib, has entered full review for authorization in Europe following its approval by the U.S. Food and Drug Administration (FDA).

HLB announced on the 7th that its U.S. subsidiary, Elevar Therapeutics, received notification from the European Medicines Agency (EMA) that the review of its Marketing Authorisation Application (MAA) for lirafugratinib has commenced.

On September 14 (local time), Elevar submitted an MAA to the EMA for lirafugratinib as a second-line treatment for patients with advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements.

The company subsequently received notification of the review's formal commencement from the EMA on October 1. Following this notice, the European regulatory pathway for lirafugratinib has officially moved into full evaluation.

Lirafugratinib received full FDA approval in the United States on September 23 under the brand name LYRFIGTU. Elevar plans to launch LYRFIGTU directly in the U.S. market in the fourth quarter of this year, and aims to accelerate its European market expansion following the start of the EMA's review.

Elevar is also pursuing development to expand lirafugratinib's therapeutic reach to other solid tumors. The company is currently conducting "ReFocus 202," a global Phase 2 clinical trial involving patients with diverse solid tumors harboring FGFR2 fusions or rearrangements, evaluating its potential as a tumor-agnostic treatment.

Kim Dong-gun, CEO of Elevar Therapeutics, said, "With lirafugratinib—which received full U.S. approval as LYRFIGTU—entering full regulatory review in Europe, our steps toward expanding into the global market are progressing smoothly. Elevar will faithfully respond to the EMA review while simultaneously driving U.S. commercialization and label expansion to continuously elevate lirafugratinib's global value."

Moon Jeong-woo

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