HLB Says FDA Conditionally Accepts U.S. Product Name "LYRFIGTU" for Cholangiocarcinoma Drug

[Financial News] HLB said on the 21st that "LYRFIGTU," the U.S. product name for lirafugratinib, a cholangiocarcinoma treatment being developed by its U.S. subsidiary Elevar Therapeutics, had been conditionally accepted by the U.S. Food and Drug Administration (FDA).
The decision was part of the product-name review process ahead of marketing approval for the new drug. If lirafugratinib receives final FDA approval, LYRFIGTU will be confirmed as its official product name.
Lirafugratinib is a second-line treatment for patients with advanced or metastatic cholangiocarcinoma involving fibroblast growth factor receptor 2 (FGFR2) fusions or rearrangements and is currently under priority review by the FDA. The target action date is the 25th. The product name LYRFIGTU was designed to emphasize its high selectivity for FGFR2 and was developed in accordance with FDA guidelines on proprietary drug names.
Lirafugratinib is an irreversible inhibitor that selectively targets FGFR2 among the FGFR family. It binds selectively to FGFR2 to produce sustained inhibition and was designed to reduce side effects caused by off-target inhibition, a limitation of existing FGFR inhibitors.
In the global Phase 1/2 ReFocus trial, patients with cholangiocarcinoma involving FGFR2 fusions or rearrangements recorded an objective response rate (ORR) of 46.5% and a median duration of response (mDOR) of 11.8 months.
Kim Dong-geon, CEO of Elevar Therapeutics, said, "Conditional acceptance of the product name is an important step toward final approval. We are making every effort to respond to the FDA's review to provide cholangiocarcinoma patients with a new treatment option, and are focusing our resources on preparations so that we can quickly launch the product in the U.S. market following approval."
[email protected] Choi Doo-sun Reporter