HLB’s lirafugratinib wins FDA priority review, eyes Sept. decision in biliary tract cancer

HLB said its U.S. subsidiary, Elevar Therapeutics, received notification from the U.S. FDA last Friday regarding the acceptance of its New Drug Application (NDA) for lirafugratinib.

The FDA has granted priority review for lirafugratinib as a second-line treatment for biliary tract cancer, with a final approval decision expected by Sept. 27.

The drug is being developed as a second-line treatment for biliary tract cancer in patients with FGFR2 fusions or rearrangements.

Under Priority Review, the FDA shortens the review period from the standard 10 months to six months. A regulatory decision is expected by Sept. 27.

Elevar Therapeutics intends to focus all resources on securing approval and moving toward commercialization, citing clinical data that demonstrates the drug's competitive edge over existing treatments.

lirafugratinib recorded an objective response rate (ORR) of 47 percent in a phase 2 clinical trial. Regarding safety, the treatment profiles were reported to be predictable and manageable through dosage adjustments.

“The fact that lirafugratinib has entered the final review process with a shortened timeline via Priority Review is an incredibly encouraging signal for the company’s value,” Elevar Therapeutics CEO Kim Dong-gun said. “We will concentrate our entire organization’s capabilities on major milestones, including the approval and commercialization of our liver cancer treatment by July and the biliary tract cancer drug by September.”

The company will also accelerate ongoing clinical trials for lirafugratinib as a tumor-agnostic therapy, Kim added.