The U.S. Food and Drug Administration approved Lyrfigtu (lirafugratinib) for adults with previously treated bile duct cancer. This approval targets patients with unresectable, locally advanced, or metastatic cholangiocarcinoma. Eligible patients must also have a fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement.
Relay Therapeutics discovered the treatment before licensing it to Elevar Therapeutics. Elevar now holds global commercialization rights for the drug. The company expects to make Lyrfigtu available in the U.S. by the fourth quarter of 2026.
The regulatory milestone validates Relay’s proprietary drug discovery platform. Relay is now eligible for significant milestone payments and future royalties on global sales.