Elevar Submits EMA Marketing Application For Lirafugratinib In Cholangiocarcinoma

Elevar Advances EMA Filing for Lirafugratinib as Second-Line Option for Metastatic Cholangiocarcinoma

(Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. (028300.KQ), announced that it submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for lirafugratinib as a second-line treatment for patients with advanced/metastatic cholangiocarcinoma (CCA) harbouring FGFR2 fusions.)

Cholangiocarcinoma is a malignancy originating in the bile ducts that transport digestive fluid bile. Frequently identified at propogated stages, it presents significant therapeutic obstacles for clinicians. (Source: Mayo Clinic)

Lirafugratinib is an investigational irreversible inhibitor that selectively engages FGFR2, distinguishing it from existing pan‑FGFR inhibitors. As a component of the fibroblast growth factor receptor (FGFR) receptor family, FGFR2 comprises one of four distinct subtypes.

The submission rests upon data from the Phase 1/2 ReFocus study, which defined the objective response rate (ORR) as its principal efficacy endpoint.

In studies involving advanced/metastatic FGFR2‑fusion cholangiocarcinoma patients who had received prior systemic therapy, lirafugratinib demonstrated a 46.5% objectively measured response rate, assessed by an independent review panel.

“We will continue to advance the regulatory pathways in the United States and European Union,” commented Dong‑Gar Kim, chief executive officer of Elevar.

Significantly, lirafugratinib earned Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in 2022 and Breakthrough Therapy Designation in 2023.

Elevar formally submitted a New Drug Application (NDA) for lirafugratinib to the FDA in January 2026, obtaining Priority Review status. Current reviews progress toward a potential PDUFA decision targeted for September 25, 2026.

Complementary to the approval narrative, Elevar operates ReFocus202, a Phase 2 clinical investigation evaluating lirafugratinib across varied solid tumour settings containing FGFR2 rearrangements or fusions. Enrollment is actively proceeding through research sites spanning the EU, United Kingdom, South Korea, and the United States.

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