HLB(028300) said on the 24th that it completed a late-cycle meeting with the U.S. Food and Drug Administration (FDA) for the cholangiocarcinoma drug candidate "lirafugratinib" without any particular issues.
HLB's U.S. subsidiary Elevar Therapeutics discussed postmarketing requirements (PMR) and postmarketing commitments (PMC) in a meeting with the FDA on the 23rd (local time). According to the company, there have been no particular differences of opinion with the FDA in the review process so far, and no new review items that could affect approval were raised.
A late-cycle meeting is an official procedure at the final stage of the review to check remaining issues and coordinate product labeling and postmarketing plans on the premise of approval.
Whether the FDA would conduct a pre-approval inspection (PAI) of the active pharmaceutical ingredient (API) and drug product (DP) manufacturing sites for lirafugratinib was not separately mentioned at this meeting. The facilities are in Canada and the United States, respectively, and both underwent current good manufacturing practice (cGMP) inspections by the FDA last year.
Lirafugratinib is an oral small-molecule targeted anticancer drug designed to selectively inhibit FGFR2, a cancer-causing gene alteration. After receiving orphan drug designation (ODD) from the FDA in 2022, it was designated a breakthrough therapy in 2023, and in March it was selected for priority review (fast track). It is currently under accelerated approval based on phase 2 results, and the approval decision is scheduled for Sept. 25 (U.S. Eastern time).
Kim Dong-geon, Elevar's CEO, said, "This late-cycle meeting confirmed that the review for lirafugratinib is entering the final stage," and added, "As there are no particular differences with the FDA so far, we will complete the follow-up procedures without delay and do our best through the approval decision in September."
Meanwhile, HLB is also pushing to resubmit for approval of the first-line liver cancer therapy using the combination regimen of "Rivoceranib·Camrelizumab." The API manufacturing site for Rivoceranib, which had been the cause of the earlier complete response letter (CRL), recently received a voluntary action indicated (VAI) rating from the FDA, resolving the facility-related issues. Elevar is currently discussing the resubmission process with the FDA and coordinating the resubmission schedule with its partner, Jiangsu Hengrui Pharmaceuticals.