HLB完成胆管癌药物lirafugratinib的FDA后期审评会议，PDUFA仍在9月25日

HLB has concluded a "late-cycle review meeting" with the U.S. Food and Drug Administration (FDA) regarding the approval review of its targeted anticancer drug "lirafugratinib" as a second-line treatment for bile duct cancer. The final approval decision will be made in September.
Elevar Therapeutics, HLB's U.S. subsidiary, said it held the late-cycle review meeting with the FDA on the 23rd, discussing "post-marketing requirements (PMR)" and "post-marketing commitments (PMC)." According to the company, there were no significant disagreements on the progress of the review, and no new review items were raised.
The late-cycle review meeting is a formal procedure in which the applicant and the FDA review remaining issues in advance before the drug approval review. With the possibility of drug approval in mind, the two sides coordinate matters such as labeling and post-marketing implementation plans together.
According to Elevar, whether the FDA would conduct a pre-approval inspection (PAI) of the manufacturing facilities for lirafugratinib's active pharmaceutical ingredient (API) and drug product (DP) was not separately mentioned at this meeting. The two manufacturing facilities are located in Canada and the United States, respectively, and both underwent the FDA's current good manufacturing practice (cGMP) inspection last year.
Lirafugratinib is an oral small-molecule targeted anticancer drug designed to selectively inhibit FGFR2. It was designated as an FDA orphan drug (ODD) in 2022 and a breakthrough therapy (BTD) in 2023. The FDA's scheduled approval decision date is September 25 (U.S. Eastern Time).
"This meeting confirmed that the approval review for lirafugratinib is progressing to its final stage," said Kim Dong-gun, CEO of Elevar. "We will complete the subsequent procedures without disruption and do our best up to the approval decision."