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Pemigatinib was the first targeted therapy for bile duct cancer, for tumours with an FGFR2 gene fusion.
Pemigatinib is a selective oral inhibitor of FGFR1, 2 and 3, blocking the constitutively active receptor produced when FGFR2 is fused to another gene. It is used in previously treated cholangiocarcinoma with an FGFR2 fusion or rearrangement and was the first targeted therapy approved for bile duct cancer. FIGHT-202 showed an ORR of 37%, median PFS of 7.0 months and median OS of 17.5 months, with no responses in other FGF/FGFR alterations; accelerated approval followed in April 2020 (EU 2021), and it is also approved for FGFR1-rearranged myeloid and lymphoid neoplasms. Hyperphosphataemia (60%), alopecia, diarrhoea, nail toxicity and serous retinal detachment are on-target effects needing phosphate binders and eye checks. First-line FIGHT-302 was discontinued, so its place remains second line. For a newcomer, it is the first pill that targets a specific gene change in bile duct cancer.
Selective oral FGFR1-3 inhibitor. Connects to FGFR2.
1.Enters tumour cell
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. FGFR2 fusion documented.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA722 · SMC advice: pemigatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 6.4 years later, when the FDA's table was read.
| Region | Year | Indication |
|---|---|---|
| US | 2020 | Previously treated FGFR2-fusion/rearranged cholangiocarcinoma (accelerated) |
| EU | 2021 | Same |
| UK | 2021 | Locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement after systemic therapy; NICE TA722 recommended 25 August 2021 with a commercial arrangement · https://www.nice.org.uk/guidance/ta722 |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Hyperphosphataemia | 60% | - |
| Alopecia | 49% | - |
| Diarrhoea | 47% | - |
| Nail toxicity | 43% | - |
| Serous retinal detachment | 4% | - |
FIGHT-202. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Pemigatinib" OR ABSTRACT:"Pemigatinib" OR TITLE:"Pemazyre" OR ABSTRACT:"Pemazyre") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Pemigatinib, not a curated reading list.
Shares FGFR2 fusions and rearrangements, FGFR1, FGFR2 fusion or rearrangement, Infigratinib.
Shares FGFR2 fusions and rearrangements, ctDNA-guided switching among FGFR inhibitors, FGFR2, Intrahepatic cholangiocarcinoma.
Shares ctDNA-guided switching among FGFR inhibitors, FGFR2, Intrahepatic cholangiocarcinoma, Biliary tract cancer (cholangiocarcinoma).
Shares FGFR1, FGF / FGFR signalling, Proteoglycans in cancer, FGFR2.
Shares Intrahepatic cholangiocarcinoma, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.
Shares Intrahepatic cholangiocarcinoma, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.
Shares Intrahepatic cholangiocarcinoma, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.
Shares Intrahepatic cholangiocarcinoma, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.