On September 22, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients, reported the U.S. Food and Drug Administration (FDA) has granted conditional acceptance of LYRFIGTU as the brand name for lirafugratinib, which is currently under FDA Priority Review as a treatment option for patients with advanced/metastatic cholangiocarcinoma (CCA) harboring FGFR2 fusion or other rearrangement.
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The proposed name Lyrfigtu (pronounced leer fig tu) was developed in accordance with the FDA’s guidance on proprietary names. Final acceptance of the Lyrfigtu brand name will be established upon FDA approval of lirafugratinib. In January, the FDA accepted Elevar’s new drug application for lirafugratinib and subsequently granted Priority Review to the application and assigned a Prescription Drug User Fee Act target action date of September 25, 2026.
"The FDA’s conditional acceptance of the Lyrfigtu brand name represents another important milestone in Elevar’s effort to potentially commercialize lirafugratinib and, if approved, introduce a new therapeutic option for patients confronted with cholangiocarcinoma," said Dong-Gun Kim, chief executive officer of Elevar. "With the PDUFA date set for later this month, we are hopeful of a positive result and highly focused on preparing for a potential launch to make the drug available to doctors and patients as quickly as possible, subject to FDA approval."
CCA, also known as bile duct cancer, is rare, with about 8,000 people in the U.S. newly diagnosed each year, according to the American Cancer Society.
In the Phase 1/2 ReFocus trial (NCT04526106), lirafugratinib demonstrated a confirmed objective response rate (ORR) of 46% and a median duration of response of 11.8 months in patients with the proposed indication. Its safety profile in the clinical data is being evaluated by the FDA as part of the ongoing review process. Adverse events observed in the trial were managed through dose adjustments.
About Lirafugratinib
Lirafugratinib (aka RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors. Lirafugratinib is an investigational product candidate and has not been approved by the U.S. Food and Drug Administration for any indication. Elevar has an exclusive license to lirafugratinib from Relay Therapeutics, Inc. for commercialization worldwide.
(Press release, Elevar Therapeutics, SEP 22, 2026, View Source [SID1234671015])