HLB's Cholangiocarcinoma Drug Candidate Designated for FDA Priority Review

Review Period Shortened to 6 Months
Approval Decision Expected by September

HLB's new drug candidate for cholangiocarcinoma has been designated for Priority Review by the U.S. Food and Drug Administration (FDA) and has entered the formal review process. The approval decision is expected to be made by the end of September 2026.

HLB company logo image. HLB

HLB announced on March 30 that its U.S. subsidiary, Elevar Therapeutics (hereinafter "Elevar"), received notice from the FDA on March 27 (local time) that the agency has begun the formal review of the new drug application for "lirafugratinib" as a second-line treatment for cholangiocarcinoma with FGFR2 fusion and rearrangement.

The FDA has designated this application for Priority Review. As a result, the typical review period of 10 months has been shortened to approximately 6 months. The final decision on approval is expected by September 27, 2026.

In clinical trials, lirafugratinib achieved an objective response rate of 47%. This is higher than the rates for existing FGFR inhibitors, such as pemigatinib (36%) and futibatinib (42%). The company also stated that, in terms of safety, the drug could be managed at a controllable level through dose adjustment.

Elevar plans to focus on preparing for regulatory approval and commercial launch, taking this Priority Review designation as an opportunity. The company also aims to accelerate development by concurrently expanding ongoing clinical trials to additional cancer types.

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