HLB’s FDA Late-Cycle Meeting for Lirafugratinib Concludes Without Major Issues

HLB has completed its Late Cycle Meeting (a late-stage FDA review conference) with the U.S. Food and Drug Administration (FDA) for the approval review of lirafugratinib, an FGFR2-targeted anticancer agent for second-line treatment of cholangiocarcinoma, without any particular issues.

According to HLB’s U.S. subsidiary, Elevar Therapeutics, on July 23 (local time), there were no significant disagreements with the FDA regarding the current review process, and no new review matters with the potential to affect approval were raised.

The Late Cycle Meeting is an official procedure held at the final stage of approval review, where any remaining issues are checked. At the same time, next steps such as labeling and post-marketing commitments are coordinated in advance, with the possibility of approval in mind.

The matter of whether the FDA will conduct a pre-approval inspection (PAI) of the manufacturing facilities for lirafugratinib’s active pharmaceutical ingredient (API) and drug product (DP) was not specifically discussed during this meeting. The two manufacturing sites are located in Canada and the United States, respectively, and both underwent general cGMP inspections by the FDA last year.

Lirafugratinib is a highly selective, orally administered, small-molecule targeted anticancer therapy designed to selectively inhibit FGFR2. It was designated as an Orphan Drug (ODD) by the FDA in 2022 and as a Breakthrough Therapy (BTD) in 2023. This year, its New Drug Application (NDA) was assigned to the Priority Review pathway. The FDA’s approval decision (PDUFA Date) is scheduled for September 25, Eastern Time.

Donggun Kim, CEO of Elevar Therapeutics, stated, “This Late Cycle Meeting confirmed that the approval review for lirafugratinib is progressing toward its final stage. As there have been no particular differences with the FDA concerning the review so far, we will do our best to complete all subsequent procedures smoothly to secure approval by September.”

This content was produced with the assistance of AI translation services.