HLB completes late-cycle FDA meeting for lirafugratinib; approval decision expected in September

HLB said it has completed a late-cycle meeting with the US Food and Drug Administration regarding the approval review of lirafugratinib, its FGFR2-targeted anticancer drug, as a second-line treatment for cholangiocarcinoma, with no significant issues arising.

According to HLB, its US subsidiary Elevar Therapeutics held the late-cycle meeting with the FDA on Thursday to discuss post-marketing requirements (PMR) and post-marketing commitments (PMC).

The company said there were no notable disagreements with the FDA over the current state of the review, and no new issues were raised that could affect approval. A late-cycle meeting is a formal procedure conducted in the final stages of a regulatory review to examine remaining points of contention and coordinate follow-up steps — including labeling and post-marketing plans — on the assumption that approval is forthcoming.

The meeting did not separately address whether the FDA would conduct a pre-approval inspection of the active pharmaceutical ingredient and finished drug product manufacturing facilities. Those facilities are located in Canada and the United States, and all completed routine current good manufacturing practice inspections by the FDA last year.

Lirafugratinib is an oral small-molecule targeted anticancer drug that selectively inhibits FGFR2. It received FDA Orphan Drug Designation in 2022 and Breakthrough Therapy Designation in 2023, and was selected this year for Priority Review under a new drug application. The FDA's Prescription Drug User Fee Act target date for an approval decision is Sept. 25.

Kim Dong-geon, chief executive of Elevar Therapeutics, said the meeting confirmed that the approval review of lirafugratinib has entered its final stage. "We will prepare all follow-up procedures without delay ahead of the approval decision in September," he said.

HLB is also accelerating the resubmission process with the FDA for rivoceranib combined with camrelizumab, a new drug candidate for first-line liver cancer treatment. The manufacturing facility for the rivoceranib active pharmaceutical ingredient — previously cited in a complete response letter — recently received a final Voluntary Action Indicated rating from the FDA, resolving the outstanding issue. HLB said it is now working with its partner Hengrui Pharmaceuticals to proceed with the resubmission.