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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 descriptionEpidemiology

Incidence of Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma

8 evidence topics · 11 sources

Summary: incidence of cholangiocarcinoma and of the FGFR2 fusion-positive previously treated population

No registry reports the incidence of previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma. It is estimated from the incidence of cholangiocarcinoma, the frequency of FGFR2 fusions or rearrangements, and the proportion of participants who reach later-line therapy. The American Cancer Society estimates that about 8,000 people in the United States are diagnosed with bile duct cancer each year, and notes that the true number is likely higher because some cases are misclassified. In the Surveillance, Epidemiology, and End Results program, the age-adjusted incidence of intrahepatic cholangiocarcinoma rose 148.8% between 2001 and 2017, from 0.80 to 1.99 per 100 000 person-years, while extrahepatic cholangiocarcinoma rose 7.5%.

FGFR2 fusions or rearrangements are reported in 10% to 16% of intrahepatic cholangiocarcinomas and in 9.2% of 6,802 cholangiocarcinoma samples profiled in one genomic dataset (see 2.2.1.2.2). Only part of the incident population reaches second-line treatment: ABC-06 reported that 15% to 25% receive second-line therapy, and 46% of 413 participants in a United States commercial-claims cohort with advanced biliary tract cancer initiated a second line. Relay Therapeutics estimated that FGFR2-mediated cancers of all tumour types affect approximately 11,000 late-line patients annually in the United States.

Incidence: estimated new United States cases and deaths in 2026
Cancer siteEstimated new cases, both sexesEstimated deaths, both sexes
Liver and intrahepatic bile duct“42,340”“30,980”
Gallbladder and other biliary“12,640”“4590”
All sites“2,114,850”“626,140”
Incidence: global estimates for 2024
Cancer siteEstimated new cases worldwide, 2024Percentage of all casesEstimated deaths worldwide, 2024
Liver and intrahepatic bile duct“843,045”“4.1”“732,489”
Gallbladder“126,384”“0.6”“92,029”