HLB's Cholangiocarcinoma Drug Name Conditionally Accepted by FDA

HLB's U.S. subsidiary, Elevar Therapeutics, has received U.S. Food and Drug Administration (FDA) conditional acceptance for the U.S. product name 'LYRFIGTU' for its FGFR2-targeted anticancer drug, lirafugratinib, which is currently under development.

According to HLB on September 21, the FDA conditionally accepted the product name ahead of new drug approval. If lirafugratinib receives final approval, 'LYRFIGTU' will become the official product name.

Lirafugratinib is currently under FDA priority review as a second-line treatment for patients with advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 fusions or rearrangements. The FDA's target action date for review is September 25, 2026.

The product name LYRFIGTU was designed to emphasize its high selectivity for FGFR2 and was developed in accordance with the FDA’s proprietary naming guidelines.

Lirafugratinib is an irreversible inhibitor that selectively targets FGFR2 among FGFR family members and is designed to minimize side effects from off-target inhibition—a known limitation of existing FGFR inhibitors. In particular, it binds selectively to FGFR2, providing sustained inhibitory effects.

In the global Phase 1/2 clinical trial, ReFocus, among cholangiocarcinoma patients with FGFR2 fusion or rearrangement, lirafugratinib demonstrated an objective response rate (ORR) of 46.5% and a median duration of response (mDOR) of 11.8 months.

Donggun Kim, CEO of Elevar, stated, "The FDA’s conditional acceptance of the product name is another significant milestone as we approach the final approval of lirafugratinib. We are fully committed to preparing for the final review to ensure we can provide a new treatment option for cholangiocarcinoma patients, and at the same time, are focusing our efforts on a swift product launch following approval."

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