# Sorafenib

Source: https://onco.cc/drugs/sorafenib/  
OnCo record `sorafenib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Nexavar
- 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.
- Approvals: US 2005: Advanced RCC; US 2007: Unresectable HCC; US 2013: Radioiodine-refractory differentiated thyroid cancer
- Dosing: Oral; 400 mg twice daily continuously
- Toxicity (grade 3+): Diarrhoea 8%; Hand-foot skin reaction 8%; Fatigue 4%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Sorafenib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Sorafenib

## Connected records

- cancers: [Acute myeloid leukaemia in children](https://onco.cc/cancers/aml-paediatric/), [Advanced hepatocellular carcinoma (BCLC C)](https://onco.cc/cancers/hcc-advanced/), [Chordoma](https://onco.cc/cancers/chordoma/), [Desmoid tumour](https://onco.cc/cancers/desmoid-tumour/), [Early hepatocellular carcinoma (BCLC 0 and A)](https://onco.cc/cancers/hcc-early/), [Follicular thyroid cancer](https://onco.cc/cancers/follicular-thyroid-cancer/), [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/), [Papillary thyroid cancer](https://onco.cc/cancers/papillary-thyroid-cancer/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/), [Thyroid cancer](https://onco.cc/cancers/thyroid/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BRAF](https://onco.cc/targets/braf/), [CRAF (RAF1)](https://onco.cc/targets/raf1/), [VEGF / VEGFR](https://onco.cc/targets/vegf/)
- companies: [Bayer](https://onco.cc/companies/bayer/), [Natco Pharma](https://onco.cc/companies/natco/)
- trials: [4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma](https://onco.cc/trials/nct00943449/), [AAML1031](https://onco.cc/trials/aaml1031/), [Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma](https://onco.cc/trials/nct07787429/), [ORIENT-32](https://onco.cc/trials/orient-32/), [REFLECT](https://onco.cc/trials/reflect/), [SARAH and SIRveNIB](https://onco.cc/trials/sarah-sirvenib/), [SHARP](https://onco.cc/trials/sharp/), [Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Rece](https://onco.cc/trials/nct03755791/), [Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Bu](https://onco.cc/trials/nct05822752/), [ZGDH3 (donafenib vs sorafenib)](https://onco.cc/trials/zgdh3/)
- ideas: [Voluntary licences and price caps for patented cancer drugs in low-income countries](https://onco.cc/ideas/idea-cost-voluntary-licensing-oncology/)
- key papers: [AAML1031: sorafenib combined with chemotherapy for children with high allelic ratio FLT3-ITD acute myeloid leukaemia](https://onco.cc/key-papers/paper-aaml1031-sorafenib-flt3-pollard-jco-2022/), [DECISION: sorafenib in radioactive iodine-refractory differentiated thyroid cancer](https://onco.cc/key-papers/paper-decision-sorafenib-lancet-2014/), [REFLECT: lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma](https://onco.cc/key-papers/paper-reflect-lenvatinib-lancet-2018/), [SHARP: sorafenib in advanced hepatocellular carcinoma](https://onco.cc/key-papers/paper-sharp-sorafenib-nejm-2008/), [STORM: adjuvant sorafenib after resection or ablation of hepatocellular carcinoma](https://onco.cc/key-papers/paper-storm-adjuvant-sorafenib-bruix-lancet-oncol-2015/)
- terms: [Hand-foot syndrome and hand-foot skin reaction](https://onco.cc/terms/hand-foot-syndrome/), [Nexavar compulsory licence (India, 2012)](https://onco.cc/terms/nexavar-compulsory-licence/), [Radioiodine therapy (I-131)](https://onco.cc/terms/radioiodine-term/)
- pathways: [Hepatocellular carcinoma (KEGG map)](https://onco.cc/pathways/hepatocellular-carcinoma-signalling/), [The angiogenic switch & tumour vessels](https://onco.cc/pathways/angiogenic-switch/), [Thyroid cancer (KEGG map)](https://onco.cc/pathways/thyroid-cancer-signalling/)

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