Wire · opportunities
FDA Approves Lirafugratinib for Pretreated, Locally Advanced or Metastatic Cholangiocarcinoma
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Fusion42 · 23 September 2026 · Fusion42 review
The FDA has approved lirafugratinib (Lyrfigtu) for adult patients with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 gene fusion or rearrangement, based on results showing a 46% objective response rate and median duration of response of 11.8 months in the REFOCUS trial.
This Wire brief sits within Fusion42's coverage of Biotech, and 10 sources have reported it between 16 Sep 2026 and 5 Oct 2026.
◆ ◆ The Wire takeaway
You now have a new regulatory route to market for FGFR2-targeted therapies in cholangiocarcinoma. This approval means competition and partnership opportunities have increased for treatments targeting FGFR2 gene fusions.
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10 sources · first reported 16 Sep 2026 · latest 5 Oct 2026
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