HLB announced on Monday that its U.S. subsidiary, Elevar Therapeutics, recently received notification from the U.S. Food and Drug Administration (FDA) accepting the filing for lirafugratinib as a second-line treatment for cholangiocarcinoma targeting FGFR2 fusions and rearrangements.
The FDA has granted lirafugratinib Priority Review status, shortening the review period from the standard 10 months to just 4 months. This means a decision on the drug’s approval will be made before September 27.
Elevar Therapeutics plans to focus all efforts on securing approval and commercializing lirafugratinib, as it has demonstrated superior data compared to competing drugs.
Lirafugratinib achieved an impressive objective response rate (ORR) of 47%, outperforming currently approved pan-FGFR inhibitors pemigatinib (36%) and futibatinib (42%). Moreover, its safety profile has proven to be manageable, with predictable side effects that can be controlled through dosage adjustments.
Kim Dong-gun, Chief Executive Officer (CEO) of Elevar Therapeutics, stated that the acceptance of lirafugratinib for filing and the expedited review process are highly encouraging signs for the company’s value. It will concentrate the efforts on major milestones, including the approval and commercialization of the liver cancer drug in July and the cholangiocarcinoma drug in September.
He added that it will also accelerate the ongoing clinical trials of lirafugratinib as a potential cancer treatment for various types.