OnCo
drugsProductApproved2005🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Sorafenib

The first drug ever to extend life in advanced liver cancer (2007), now mostly a comparator arm that newer combinations are measured against.

SHARP: OS 10.7 vs 7.9 months versus placebo (HR 0.69). Standard first-line therapy for a decade until REFLECT (lenvatinib non-inferior) and IMbrave150 (atezolizumab-bevacizumab superior). Also approved in RCC and radioiodine-refractory thyroid cancer. Hand-foot skin reaction and diarrhoea dominate toxicity.

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Sorafenib
PubChem
Mechanism, step by step
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1.Enters tumour and endothelial cells

Modality
Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, RAF)
Mechanism
Oral inhibitor of VEGFR1-3, PDGFR-β, KIT, FLT3 and RAF kinases; anti-angiogenic and anti-proliferative.
Brand / code
Nexavar
Dosing & schedule
Route
Oral
Schedule
400 mg twice daily continuously
Dose modifications
Dose reduction to 400 mg daily for grade 2-3 hand-foot skin reaction
Monitoring
Blood pressure, skin, liver function
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). Generic sorafenib is available.

Commercial insurance
covered on label

Multi-source generic on low-cost tiers; usually no prior authorisation. Cash prices without insurance are modest. Plans require the generic.

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.

NICE recommendedNICE TA474 · 2017SMC: accepted
Appraised for
Advanced HCC (Child-Pugh A)
Notes
Originally rejected (TA189, 2010) and funded via the old CDF; recommended after a price cut. Also differentiated thyroid cancer (TA535, 2018).
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA474 · SMC advice: sorafenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 16 Nov 2007ApprovalUS

    Unresectable HCC on SHARP

Approvals

RegionYearIndication
US2005Advanced RCC
US2007Unresectable HCC
US2013Radioiodine-refractory differentiated thyroid cancer

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Diarrhoea
39%
8%
Hand-foot skin reaction
21%
8%
Fatigue
22%
4%

SHARP. 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
564 studies3 recruiting80 Phase 223 Phase 3
Search “Sorafenib” 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
Sorafenib
intervention: Sorafenib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend857 papers in the last 12 months-3% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Sorafenib" OR ABSTRACT:"Sorafenib" OR TITLE:"Nexavar" OR ABSTRACT:"Nexavar") 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 Sorafenib, not a curated reading list.

Connected

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