FDA approves Lyrfigtu for previously treated FGFR2-altered cholangiocarcinoma
The FDA has approved Lyrfigtu for adults with previously treated FGFR2-altered cholangiocarcinoma, adding a new targeted therapy for this molecularly defined group of bile duct cancers.
Lyrfigtu, or lirafugratinib, is approved for unresectable, locally advanced or metastatic cholangiocarcinoma harbouring an FGFR2 fusion or other rearrangement after prior treatment.
The approval was supported by the REFOCUS study and expands the range of precision medicines available for patients whose tumours are driven by FGFR2 alterations.
Field | Content |
Alert Type | Approval |
Drug Name | Lirafugratinib |
Brand Name | Lyrfigtu |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | New drug approval |
Indication | Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement |
Therapy Area(s) | Oncology; cholangiocarcinoma; biliary tract cancer |
Biomarker | FGFR2 fusion or rearrangement |
Technology or Modality | Targeted small-molecule FGFR inhibitor |
Clinical Study | REFOCUS |
Geography | United States |
What Happened | The FDA approved Lyrfigtu for adults with previously treated FGFR2-altered cholangiocarcinoma. |
Why It Matters | The approval provides another biomarker-directed treatment option for a difficult-to-treat cancer in which FGFR2 alterations define an actionable molecular subgroup. |
Supporting Context | FGFR2 fusions and rearrangements occur in a subset of intrahepatic cholangiocarcinomas and can drive tumour growth. |
Key Takeaway | Lyrfigtu adds a new FDA-approved targeted therapy for previously treated FGFR2-altered cholangiocarcinoma. |
What to Watch | Clinical uptake, molecular testing rates and positioning against other FGFR-targeted therapies in cholangiocarcinoma. |
Primary Source | U.S. Food and Drug Administration |
Relevant Date | 23 September 2026 |
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