Name: Lirafugratinib (Lyrfigtu) in Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma: Reversible FGFR inhibitors
Published: 2026-09-27T09:44:05-04:00

Product information and disease description Place of product in therapy Approaches to treatment Current treatment options and standard of care

Reversible FGFR inhibitors

4 evidence topics · 5 sources

Guideline recommendations for FGFR inhibition after progression

“Futibatinib [ESMO-Magnitude of Clinical Benefit (MCBS) v1.1 score: 3] and pemigatinib (ESMO-MCBS v1.1 score: 2) are recommended in patients with FGFR2 fusions or rearrangements who have progressed after one or more prior lines of systemic therapy [III, A; ESCAT score: I-B].” (opens the source at this quote in a new tab)
“These findings led to both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approval of pemigatinib and futibatinib.” (opens the source at this quote in a new tab)

“FGFR inhibitors are recommended for the treatment of patients with FGFR2 fusions who have progressed after ≥1 prior line of systemic therapy [III, A; ESMO-MCBS v1.1 score: 3; ESCAT score: I-B]” (opens the source at this quote in a new tab)

Pemigatinib: FIGHT-202 final analysis

“The ORR in cohort A was 37.0% (95% confidence interval 27.9% to 46.9%); complete and partial responses were observed in 3 and 37 patients, respectively.” (opens the source at this quote in a new tab)
“Median DOR was 9.1 (6.0-14.5) months; median PFS and OS were 7.0 (6.1-10.5) months and 17.5 (14.4-22.9) months, respectively.” (opens the source at this quote in a new tab)
“The most common TEAEs of any grade were hyperphosphatemia (58.5%), alopecia (49.7%), and diarrhea (47.6%).” (opens the source at this quote in a new tab)

Pemigatinib: FIGHT-202 primary analysis

“38 (35·5% [95% CI 26·5–45·4]) of 107 patients with FGFR2 fusions or rearrangements achieved a centrally confirmed objective response (table 2).” (opens the source at this quote in a new tab)

Infigratinib: phase 2 trial in previously treated FGFR2 fusion-positive cholangiocarcinoma

“After a median follow-up of 10·6 months (IQR 6·2-15·6), the BICR-assessed objective response rate was 23·1% (95% CI 15·6-32·2; 25 of 108 patients), with one confirmed complete response in a patient who only had non-target lesions identified at baseline and 24 partial responses.” (opens the source at this quote in a new tab)
“The most common treatment-emergent adverse events of any grade were hyperphosphataemia (n=83), stomatitis (n=59), fatigue (n=43), and alopecia (n=41). The most common ocular toxicity was dry eyes (n=37). Central serous retinopathy-like and retinal pigment epithelial detachment-like events occurred in 18 (17%) patients, of which ten (9%) were grade 1, seven (6%) were grade 2, and one (1%) was grade 3.” (opens the source at this quote in a new tab)