EMA notifies the start of review after 15 days of application for product approval
Following formal approval in the U.S., expansion into Europe is underway... Expansion of indications as a treatment for any type of cancer
HLB (028300)'s new drug for bile duct cancer, 'lirafugratinib', has entered the main approval review process in Europe following formal approval by the U.S. Food and Drug Administration (FDA). With commercialization in the United States ahead, the process of expanding the global market continues as European approval and indication expansion are simultaneously underway.
HLB announced on the 7th that its U.S. subsidiary Elevar Therapeutics had received notification from the European Medicines Agency (EMA) that the review of the marketing authorization application (MAA) for lirafugratinib had begun.
On September 14 (local time), Eleva applied for European marketing approval for rirafugratinib as a second-line treatment for patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement. EMA notified the start of the main review on October 1, about 15 days later.
Following formal approval in the U.S., European approval screening is also on track.
Lilafugratinib was officially approved by the FDA in the United States last September under the product name ‘LYRFIGTU’. Adult patients with previously treated locally advanced or metastatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements are eligible.
Unlike some existing FGFR-targeted treatments that entered the market through accelerated approval, Repick2 received formal approval. Elevar plans to launch ReficTwo directly in the U.S. in the fourth quarter of this year.
In Europe, the approval process has entered the next stage with the start of the EMA main review. If approval is secured in Europe following the United States, the commercialization area of rirafugratinib may expand.
From cholangiocarcinoma to solid cancer… ‘ReFocus202’ indication expansion clinical trial
Eleva is also in the process of developing rirafugratinib to expand its treatment range to solid cancers other than cholangiocarcinoma.
Currently, a global phase 2 ‘ReFocus202’ is being conducted targeting patients with various solid tumors with FGFR2 fusion or rearrangement. This is a clinical trial to develop a tumor-agnostic treatment that selects patients based on genetic mutations rather than specific cancer types.
If lirafugratinib expands its scope as a treatment for any type of cancer, there is a possibility that the treatment target will expand beyond the current patient group centered on bile duct cancer. As the U.S. launch, European approval review, and indication expansion clinical trials are being carried out in parallel, follow-up schedules to gauge the scope of global commercialization are expected to continue in the future.
Kim Dong-gun, CEO of Eleva, said, “The process for expanding the global market is progressing smoothly as rirafugratinib, which received official approval as LipicTwo in the U.S., has entered the full-scale review phase in Europe,” adding, “We will faithfully respond to the EMA review while simultaneously promoting commercialization and expansion of indications in the U.S. to continue to increase the global value of rirafugratinib.”
