HLB announced on Wednesday that its U.S. subsidiary, Elevar Therapeutics, has received notification from the European Medicines Agency (EMA) that the review process for its novel bile duct cancer drug, Lirafugratinib, has officially commenced.
On September 14, Elevar submitted a marketing authorization application (MAA) for Lirafugratinib as a second-line treatment for patients with advanced or metastatic bile duct cancer harboring FGFR2 fusions or rearrangements.
Just over two weeks later, on October 1, the company received confirmation from the EMA that the primary review had begun. This notification marks the entry of Lirafugratinib’s European approval process into its substantive review phase.
Lirafugratinib, marketed as LYRFIGTU, received full U.S. Food and Drug Administration (FDA) approval in the U.S. on September 23. Elevar plans to launch LYRFIGTU directly in the U.S. market during the fourth quarter of this year. The company also aims to expedite its entry into the European market following the initiation of the EMA review.
Elevar is actively pursuing the expansion of Lirafugratinib’s therapeutic applications to other solid tumors. The company is currently conducting a global Phase 2 trial targeting various solid tumor patients with FGFR2 fusions or rearrangements, evaluating its potential as a pan-cancer treatment.
FGFR2 (fibroblast growth factor receptor 2) is a protein crucial for cell growth and differentiation. Abnormalities such as fusions or rearrangements in the FGFR2 gene can lead to persistent abnormal signaling, promoting the growth and proliferation of cancer cells.
Kim Dong-geon, Chief Executive Officer (CEO) of Elevar, stated that the commencement of Lirafugratinib’s substantive review in Europe represents a significant milestone in the global market expansion strategy. It will continue to focus on U.S. commercialization efforts and broaden the drug’s indications, aiming to consistently enhance Lirafugratinib’s global value proposition.