medcelerator · clinician one-pager
New Oral Pill Option for Previously Treated Bile Duct Cancer
Lyrfigtu (lirafugratinib) — oral FGFR2 inhibitor for previously treated FGFR2-altered cholangiocarcinoma
FDA Approved · United States · September 25, 2026
Condition: Cholangiocarcinoma (Bile Duct Cancer)
Who this is for
This is for adults with previously treated unresectable, locally advanced, or metastatic bile duct cancer (cholangiocarcinoma) that harbors an FGFR2 gene fusion or other rearrangement — and the caregivers helping them. It explains the 23 September 2026 FDA approval of Lyrfigtu (lirafugratinib), the once-daily oral 70 mg dose, what REFOCUS (NCT04526106) showed, eye and phosphate watchpoints, and how to ask a GI / hepatobiliary oncology clinician about labelled US supply and molecular testing — without treating an EMA filing, a completed trial, or another FGFR inhibitor carton as this bottle. Authorized is not funded.
Next clinical step
This is FDA authorised, not Health Canada authorised. Ask the clinician about US care, a trial, or a Special Access Programme path in United States.
Access doors
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
FDA Expanded Access (Patient Affairs)
US Food and Drug Administration path for a licensed clinician to request an investigational medical product for a patient with a serious or immediately life-threatening condition when no comparable approved therapy is available. This is a request path, not a labelled indication. Authorized is not funded.
https://www.fda.gov/news-events/public-health-focus/expanded-access
Not medical advice. Authorized is not funded. Full piece: https://medcelerator.com/articles/lyrfigtu-lirafugratinib-fgfr2-cca