[Edaily Reporter KIM SAE-MI ] HLB INC.(028300)’s new drug for cholangiocarcinoma, “lirafugratinib,” has entered the full review process for marketing 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, Eleva Therapeutics, had received notification from the European Medicines Agency (EMA) that it had initiated a review of the Marketing Authorization Application (MAA) for lirafugratinib.

Previously, on the 14th of last month (local time), Eleva submitted an application to the EMA for European marketing authorization of lirafugratinib as a second-line or later treatment for patients with advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. Subsequently, on the 1st of this month, the company received notification from the EMA that the formal review had begun, marking the start of the full review phase of the European approval process.

Lirapugratinib is an oral, targeted anticancer drug that selectively inhibits FGFR2. On the 23rd of last month, it received full approval from the FDA in the U.S. under the brand name “LYRFIGTU.” It is indicated for patients with unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma who have previously received treatment and in whom an FGFR2 fusion or other rearrangement has been confirmed.

Elevate plans to launch “Lyfictu” directly in the U.S. in the fourth quarter of this year. With the European approval review now underway following the U.S. approval, the expansion of Lyrapugratinib’s global commercial footprint is expected to accelerate.

Clinical trials to expand the drug’s indications are also underway. Eleva is conducting a global Phase 2 clinical trial (ReFocus202) in patients with various solid tumors harboring FGFR2 fusions or rearrangements. Through this trial, the company is evaluating the drug’s potential as a “tumor-agnostic” therapy—one that treats patients based on specific biomarkers, regardless of cancer type.

Kim Dong-geon, CEO of Eleva, stated, “Lirapugratinib, which has received full approval for Repicturo in the U.S., has now entered the full review phase in Europe as well.” He added, “We will continue to enhance the global value of lirapugratinib by diligently responding to the EMA review while simultaneously advancing its commercialization in the U.S. and expanding its indications.”