OnCo
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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.

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Pemigatinib
PubChem
Mechanism, step by step
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1.Enters tumour cell

Modality
Small-molecule kinase inhibitor (FGFR1-3)
Mechanism
Selective oral FGFR1-3 inhibitor.
Brand / code
Pemazyre
Dosing & schedule
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

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.

Cancer Drugs FundNICE TA722 · 2021SMC: accepted
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.

Regulatory

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Approvals

RegionYearIndication
US2020Previously treated FGFR2-fusion/rearranged cholangiocarcinoma (accelerated)
EU2021Same

Safety

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Toxicity profile
Adverse eventAny gradeGrade 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

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
44 studies11 recruiting43 Phase 21 Phase 3
Search “Pemigatinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Pemigatinib
intervention: Pemigatinib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend49 papers in the last 12 months+4% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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