Pemigatinib
Pemigatinib was the first targeted therapy for bile duct cancer, for tumours with an FGFR2 gene fusion.
FIGHT-202: ORR 37%, median PFS 7.0 months, median OS 17.5 months in previously treated FGFR2-fusion cholangiocarcinoma; accelerated approval April 2020. Also approved in FGFR1-rearranged myeloid/lymphoid neoplasms. First-line FIGHT-302 discontinued.
1.Enters tumour cell
- Route
- Oral
- Schedule
- 13.5 mg daily for 14 days of each 21-day cycle
- Dose modifications
- Phosphate binders and dose holds for hyperphosphataemia
- Monitoring
- Serum phosphate, eye exams (retinal pigment epithelial detachment)
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- IncyteCARES
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- FGFR2 fusion or rearrangement-positive cholangiocarcinoma after 1 or more systemic therapies
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA722 · NHS England Cancer Drugs Fund list · SMC advice: pemigatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2020 | Previously treated FGFR2-fusion/rearranged cholangiocarcinoma (accelerated) |
| EU | 2021 | Same |
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductFutibatinib
Shares FGFR2 fusions and rearrangements, ctDNA-guided switching among FGFR inhibitors, FGFR2, Biliary tract cancer (cholangiocarcinoma).
- ProductTinengotinib
Shares FGFR2 fusions and rearrangements, ctDNA-guided switching among FGFR inhibitors, FGFR2, Biliary tract cancer (cholangiocarcinoma).
- TrialFIRST-308
- TrialFOENIX-CCA2
- TermIntrahepatic, perihilar, distal and gallbladder cancer
- ProductErdafitinib
Shares FGFR2, Small-molecule kinase inhibitors.
- PersonTanios Bekaii-Saab
- InstitutionNational Cancer Centre Singapore