HLB Nears FDA Review Decision on Rilvegostomig, Expects Outcome by Late September

[Financial News] HLB Co., Ltd. said on the 23rd that it has completed the final-stage "Late-Cycle Meeting" with the U.S. Food and Drug Administration (FDA) for its FGFR2-targeted anticancer drug rilvegostomig without any major issues.
As HLB has not had any significant differences with the FDA during the review process so far, the company expressed optimism that a decision on approval could come in September.
Elevar Therapeutics, HLB's U.S. subsidiary, said it held a late-cycle meeting with the FDA on the day in question, local time, and discussed post-approval implementation plans, including post-marketing requirements (PMR) and post-marketing commitments (PMC).
According to the company, there were no major disagreements with the FDA regarding the review progress so far, and no new issues were raised that could affect the approval decision.
A late-cycle meeting is an official procedure carried out at the final stage of the FDA's new drug review process. It is known as a step to review any remaining issues one last time while also coordinating product labeling and post-marketing safety plans in advance, assuming approval is likely.
The FDA's pre-approval inspection (PAI) status for the active pharmaceutical ingredient (API) and drug product (DP) manufacturing facilities for rilvegostomig was not discussed separately at the meeting. The facilities are located in Canada and the United States, respectively, and both underwent FDA current good manufacturing practice (cGMP) inspections last year.
Rilvegostomig is an oral small-molecule targeted anticancer drug designed to selectively inhibit FGFR2, and it is being developed for patients with bile duct cancer who have FGFR2 gene abnormalities.
The candidate received orphan drug designation (ODD) from the FDA in 2022 and breakthrough therapy designation (BTD) in 2023, underscoring the pace of its development.
This year, its new drug application (NDA) was granted Priority Review, and the FDA's PDUFA Date is set for Sept. 25, U.S. Eastern Time.
Kim Dong-geon, CEO of Elevar, said, "This late-cycle meeting confirmed that the review of rilvegostomig is entering its final stage." He added, "As there are no major disagreements with the FDA on the review contents so far, we will do our best to move forward without setbacks and secure an approval decision in September."
Meanwhile, HLB is also pursuing a resubmission for approval of its other key pipeline, the combination therapy of rivoceranib and camrelizumab as a first-line treatment for liver cancer.
The manufacturing facility for rivoceranib's active pharmaceutical ingredient, which had been a major reason for the FDA's earlier complete response letter (CRL), recently received a final classification of Voluntary Action Indicated (VAI), resolving the regulatory issue related to the plant.
Elevar is coordinating the resubmission schedule with its partner, Jiangsu Hengrui Pharmaceuticals, while also discussing the resubmission process with the FDA.
Industry watchers expect that if rilvegostomig's review is completed smoothly, HLB will gain fresh momentum in its push into the global anticancer drug market and that the outcome could also have a positive effect on its renewed bid for liver cancer drug approval.
[email protected] Kang Jung-mo Reporter