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 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.
Hot Picks Today
"If You Don't Apply, My KRW 1.7 Million Will Be Gone"... Unclaimed National Pension Refunds Vanish After 'This Deadline'
- "The Inner Aisles Are Dangerous, I Never Buy These": 3 Foods a Doctor Warns Against
- Lee Juwan, Who Forecast Samsung at 70,000 Won and SK hynix at 200,000 Won, Says They're "Still Overvalued"; Others Counter: "Fundamentals Are Solid, Correction Is Excessive"
- "An Opinion, Not False Information"... Man in His 40s Who Called May 18 a "Riot" on Ilbe Acquitted on Appeal
- Kang Minkyung Raved, "Worth the Money," Then It Sold Out in 10 Minutes... Convenience Store Collaborations Pay Off
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.
© The Asia Business Daily. All rights reserved. Unauthorized AI training and use prohibited.
!["Please Take Them Off!" They Made It All the Way to the Bed... Then "80% of Fecal Bacteria" Struck [Deep Scroll]](https://cwcontent.asiae.co.kr/asiaresize/307/2026101610053063338_1792112730.png)
