EMA initiates review just two weeks after marketing authorization application
Company pursues European expansion alongside U.S. launch, aiming to broaden indications as a tumor-agnostic therapy
HLB (028300) announced that its novel cholangiocarcinoma treatment, Lirafugratinib, has entered formal regulatory review in Europe following its full approval by the U.S. Food and Drug Administration (FDA). As the company prepares for commercialization in the U.S., the simultaneous progress in European regulatory filing and efforts to expand the drug's indications underscore a broad push for global market penetration.
HLB stated on the 7th that its U.S. subsidiary, Elevar Therapeutics, received notification from the European Medicines Agency (EMA) that the review of its Marketing Authorization Application (MAA) for Lirafugratinib has officially commenced.
Elevar submitted the MAA for Lirafugratinib on September 14 (local time) as a second-line treatment for patients with advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. The EMA notified the company of the initiation of the formal review on October 1, just over two weeks later.
European Review Follows Full U.S. Approval
In September, Lirafugratinib received full FDA approval under the brand name ‘LYRFIGTU’. The drug is indicated for adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma characterized by FGFR2 fusions or rearrangements.
Unlike some existing FGFR-targeted therapies that entered the market via accelerated approval pathways, LYRFIGTU secured full approval. Elevar plans to launch the drug directly in the U.S. market during the fourth quarter of this year.
In Europe, the commencement of the EMA’s formal review marks a significant milestone in the regulatory process. Securing approval in Europe would further expand the commercial footprint for Lirafugratinib following its U.S. success.
Expanding from Cholangiocarcinoma to Solid Tumors: ‘ReFocus202’ Clinical Trials
Elevar is also actively developing Lirafugratinib for use in solid tumors beyond cholangiocarcinoma.
The company is currently conducting a global Phase 2 clinical trial, ‘ReFocus202,’ targeting patients with various solid tumors harboring FGFR2 fusions or rearrangements. The study is designed to develop the drug as a tumor-agnostic therapy, which selects patients based on specific genetic mutations rather than the primary site of the cancer.
Should Lirafugratinib successfully expand into the tumor-agnostic space, the addressable patient population is expected to grow significantly beyond the current focus on cholangiocarcinoma. With the U.S. launch, European regulatory review, and trials for expanded indications progressing in parallel, the company expects a steady stream of updates regarding its global commercial roadmap.
“With Lirafugratinib—already granted full approval as LYRFIGTU in the U.S.—now entering the formal review phase in Europe, our strategy for global market expansion is moving forward smoothly,” said Dong-Gun Kim, CEO of Elevar Therapeutics. “We remain committed to engaging proactively with the EMA review process while simultaneously advancing our U.S. commercialization and clinical development to continuously enhance the global value of Lirafugratinib.”
