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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 descriptionProduct descriptionProduct information

Special populations

7 evidence topics · 2 sources

Pregnancy and pregnancy testing

“There are no available data on the use of LYRFIGTU in pregnant women.” (opens the prescribing information at this quote)

“Verify pregnancy status of females of reproductive potential prior to initiating LYRFIGTU” (opens the prescribing information at this quote)

Lactation

“Because of the potential for serious adverse reactions from LYRFIGTU in breastfed children, advise women not to breastfeed during treatment with LYRFIGTU and for 1 week after the last dose.” (opens the prescribing information at this quote)

Contraception and male fertility

“Advise females of reproductive potential to use effective contraception during treatment with LYRFIGTU and for 6 months after the last dose.” (opens the prescribing information at this quote)

“Based on findings from animal studies, LYRFIGTU may impair male reproductive function and fertility.” (opens the prescribing information at this quote)

Pediatric use and waiver of pediatric studies

“The safety and efficacy of LYRFIGTU have not been established in pediatric patients.” (opens the prescribing information at this quote)

“In a repeat-dose toxicology study, administration of lirafugratinib to rats for 3 months resulted in marked odontoblast degeneration and fracture of the incisors” (opens the prescribing information at this quote)

“We are waiving the pediatric studies requirement for this application, in pediatric patients less than 17 years of age because necessary studies are impossible or highly impracticable, due to the exceedingly low incidence of FGFR2 altered tumors.” (opens the source at this quote in a new tab)

Geriatric use

“Of the 385 patients treated with LYRFIGTU 70 mg once daily in REFOCUS, 32% were 65 years or older, and 7% of patients were 75 years or older. No clinically meaningful differences in safety or effectiveness of LYRFIGTU have been observed between patients 65 years or older and younger adult patients.” (opens the prescribing information at this quote)

Hepatic impairment

“No dosage modifications are recommended for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. LYRFIGTU has not been studied in patients with severe (Child-Pugh Class C) hepatic impairment.” (opens the prescribing information at this quote)

Renal impairment

“No clinically significant differences in the pharmacokinetics of lirafugratinib were observed based on age (20-87 years), sex, race (White 59%, Asian 16%, or Black 2.7%), body weight (34-147 kg), CLcr 30-89 mL/min (estimated by Cockcroft-Gault)” (opens the prescribing information at this quote)

“The effect of severe renal impairment (CLcr < 30 mL/min) and severe (Child-Pugh Class C) hepatic impairment on lirafugratinib pharmacokinetics is unknown.” (opens the prescribing information at this quote)