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Lirafugratinib (Lyrfigtu)

Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma

Also known as RLY-4008
Regulatory submission
NDA submitted January 2026
Last updated
158 sources

Product information and disease descriptionPlace of product in therapyDisease description

Long-term morbidity

6 evidence topics · 5 sources

Summary: cumulative morbidity in advanced and second-line disease

Long-term morbidity in advanced biliary tract cancer arises mainly from recurrent biliary obstruction and its management, by infection, and by functional decline after progression on first-line therapy. Active symptom control in the second-line setting is defined to include biliary drainage, antibiotics, analgesia, steroids, anti-emetics, palliative radiotherapy, and transfusion of blood products. In a single-centre series of 171 participants who received a palliative biliary stent, complications occurred in 91 (53%) and cholangitis was the most frequent, in 48 (53%) of those with complications; median survival was 75.5 days. In a United States claims cohort, 69.5% of participants had an all-cause inpatient hospitalization and 65.6% a biliary-tract-cancer-related hospitalization, with a mean stay of 7 days per visit and the largest share of inpatient visits occurring during third-line therapy. Rapid decline in performance status after first-line progression limits how many participants can be treated at all.