{"entity":{"id":"sorafenib","kind":"drug","name":"Sorafenib","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Sorafenib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Sorafenib"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced","rcc","thyroid","papillary-thyroid-cancer","follicular-thyroid-cancer"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf","braf"],"drugs":[],"companies":["bayer","natco"],"institutions":[],"pathways":[],"terms":[],"trials":["sharp","nct03755791","nct05822752"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"US","year":2005,"indication":"Advanced RCC"},{"region":"US","year":2007,"indication":"Unresectable HCC"},{"region":"US","year":2013,"indication":"Radioiodine-refractory differentiated thyroid cancer"}],"mechanismSteps":["Enters tumour and endothelial cells","Blocks VEGFR/PDGFR signalling in vessels, cutting blood supply","Inhibits RAF-MEK-ERK in tumour cells","Tumour growth slows; rarely shrinks"],"dosing":{"route":"Oral","schedule":"400 mg twice daily continuously","modifications":"Dose reduction to 400 mg daily for grade 2-3 hand-foot skin reaction","monitoring":"Blood pressure, skin, liver function"},"toxicity":[{"event":"Diarrhoea","anyGradePct":39,"grade3PlusPct":8,"note":"SHARP"},{"event":"Hand-foot skin reaction","anyGradePct":21,"grade3PlusPct":8,"note":"SHARP"},{"event":"Fatigue","anyGradePct":22,"grade3PlusPct":4,"note":"SHARP"}],"access":[],"regulatoryEvents":[{"date":"2007-11-16","type":"approval","region":"US","note":"Unresectable HCC on SHARP"}]},"route":"/drugs/sorafenib/","neighbours":{"cancer":[{"id":"aml-paediatric","kind":"cancer","name":"Acute myeloid leukaemia in children","route":"/cancers/aml-paediatric/"},{"id":"hcc-advanced","kind":"cancer","name":"Advanced hepatocellular carcinoma (BCLC C)","route":"/cancers/hcc-advanced/"},{"id":"chordoma","kind":"cancer","name":"Chordoma","route":"/cancers/chordoma/"},{"id":"desmoid-tumour","kind":"cancer","name":"Desmoid tumour","route":"/cancers/desmoid-tumour/"},{"id":"hcc-early","kind":"cancer","name":"Early hepatocellular carcinoma (BCLC 0 and A)","route":"/cancers/hcc-early/"},{"id":"follicular-thyroid-cancer","kind":"cancer","name":"Follicular thyroid cancer","route":"/cancers/follicular-thyroid-cancer/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"papillary-thyroid-cancer","kind":"cancer","name":"Papillary thyroid cancer","route":"/cancers/papillary-thyroid-cancer/"},{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"},{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"},{"id":"raf1","kind":"target","name":"CRAF (RAF1)","route":"/targets/raf1/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"},{"id":"natco","kind":"company","name":"Natco Pharma","route":"/companies/natco/"}],"trial":[{"id":"nct00943449","kind":"trial","name":"4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular 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When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Bu","route":"/trials/nct05822752/"},{"id":"zgdh3","kind":"trial","name":"ZGDH3 (donafenib vs sorafenib)","route":"/trials/zgdh3/"}],"idea":[{"id":"idea-cost-voluntary-licensing-oncology","kind":"idea","name":"Voluntary licences and price caps for patented cancer drugs in low-income countries","route":"/ideas/idea-cost-voluntary-licensing-oncology/"}],"paper":[{"id":"paper-aaml1031-sorafenib-flt3-pollard-jco-2022","kind":"paper","name":"AAML1031: sorafenib combined with chemotherapy for children with high allelic ratio FLT3-ITD acute myeloid leukaemia","route":"/key-papers/paper-aaml1031-sorafenib-flt3-pollard-jco-2022/"},{"id":"paper-decision-sorafenib-lancet-2014","kind":"paper","name":"DECISION: sorafenib in radioactive iodine-refractory differentiated thyroid cancer","route":"/key-papers/paper-decision-sorafenib-lancet-2014/"},{"id":"paper-reflect-lenvatinib-lancet-2018","kind":"paper","name":"REFLECT: lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma","route":"/key-papers/paper-reflect-lenvatinib-lancet-2018/"},{"id":"paper-sharp-sorafenib-nejm-2008","kind":"paper","name":"SHARP: sorafenib in advanced hepatocellular carcinoma","route":"/key-papers/paper-sharp-sorafenib-nejm-2008/"},{"id":"paper-storm-adjuvant-sorafenib-bruix-lancet-oncol-2015","kind":"paper","name":"STORM: adjuvant sorafenib after resection or ablation of hepatocellular carcinoma","route":"/key-papers/paper-storm-adjuvant-sorafenib-bruix-lancet-oncol-2015/"}],"term":[{"id":"hand-foot-syndrome","kind":"term","name":"Hand-foot syndrome and hand-foot skin reaction","route":"/terms/hand-foot-syndrome/"},{"id":"nexavar-compulsory-licence","kind":"term","name":"Nexavar compulsory licence (India, 2012)","route":"/terms/nexavar-compulsory-licence/"},{"id":"radioiodine-term","kind":"term","name":"Radioiodine therapy (I-131)","route":"/terms/radioiodine-term/"}],"pathway":[{"id":"hepatocellular-carcinoma-signalling","kind":"pathway","name":"Hepatocellular carcinoma (KEGG map)","route":"/pathways/hepatocellular-carcinoma-signalling/"},{"id":"angiogenic-switch","kind":"pathway","name":"The angiogenic switch & tumour vessels","route":"/pathways/angiogenic-switch/"},{"id":"thyroid-cancer-signalling","kind":"pathway","name":"Thyroid cancer (KEGG map)","route":"/pathways/thyroid-cancer-signalling/"}]}}