28 January 2026 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational drug lirafugratinib as a second-line treatment option for cholangiocarcinoma patients with FGFR2 fusion or rearrangement.

The new drug application is supported by positive clinical data from the Phase 1/2 ReFocus trial, in which lirafugratinib demonstrated clinically meaningful anti-tumour activity, measured by objective response rate, duration of response, and progression-free survival, as well as manageable and tolerable safety in patients with advanced/metastatic cholangiocarcinoma and other solid tumours with fibroblast growth factor receptor 2 (FGFR2) alterations.

Read Elevar Therapeutics press release