European Approval Sought for Lirafugratinib in FGFR2-Altered Metastatic Cholangiocarcinoma

A marketing authorization application (MAA) has been submitted to the European Medicines Agency (EMA) for lirafugratinib, an oral FGFR2 inhibitor, as a second-line treatment for patients with advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. This submission is based on positive results from the phase 1/2 ReFocus trial.