{"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":[],"indications":["hcc","rcc","thyroid"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"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":{"indication":[{"id":"hcc","kind":"indication","name":"Hepatocellular carcinoma","route":"/indications/hcc/"},{"id":"rcc","kind":"indication","name":"Renal cell carcinoma","route":"/indications/rcc/"},{"id":"thyroid","kind":"indication","name":"Thyroid cancer","route":"/indications/thyroid/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"term":[{"id":"radioiodine-term","kind":"term","name":"Radioiodine therapy (I-131)","route":"/terms/radioiodine-term/"}],"trial":[{"id":"sarah-sirvenib","kind":"trial","name":"SARAH and SIRveNIB","route":"/trials/sarah-sirvenib/"}],"pairing":[{"id":"tare-vs-sorafenib-caution","kind":"pairing","name":"Radioembolisation (TARE) compared with sorafenib in hepatocellular carcinoma","route":"/pairings/tare-vs-sorafenib-caution/"}]}}