Study summary

FDA approved lirafugratinib for FGFR2-altered cholangiocarcinoma

Lirafugratinib approval · 116 people, single-arm · Approved September 23, 2026

What was tested

Approval of lirafugratinib (Lyrfigtu), an FGFR2-blocking pill, for previously treated cholangiocarcinoma with an FGFR2 fusion or rearrangement, based on the single-arm REFOCUS trial.

What they found

• Tumors shrank in 46%; responses lasted a median 11.8 months.
• Label warnings include eye problems and high phosphate levels.

What it means

A third FGFR option after pemigatinib and futibatinib, designed to cause fewer side effects from blocking related receptors.