significantly longer in patients receiving sorafenib plus doxorubicin than in those receiving doxorubicin alone. A prospective single-centre phase II study which included the patients with unresectable hepatocellular carcinoma (HCC) concluding that the combination of sorafenib and DEB-TACE in patients with unresectable HCC is well tolerated and safe, with most toxicities related to sorafenib. In Australia this is the only indication for which sorafenib is listed on the PBS and hence the only government-subsidised indication for sorafenib. Along with renal cell carcinoma, hepatocellular carcinoma is one of the TGA-labelled indications for sorafenib. Thyroid cancer On 22 November 2013, sorafenib was approved by the FDA for the treatment of locally recurrent or metastatic, progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment. The phase III DECISION trial showed significant improvement in progression-free survival but not in overall survival. However, as is known, the side effects were very frequent, specially hand and foot skin reaction. Adverse effects Adverse effects by frequency Note: Potentially serious side effects are in bold. Very common (>10% frequency) Lymphopenia Hypophosphataemia Haemorrhage Hypertension Diarrhea Rash Alopecia (hair loss; occurs in roughly 30% of patients receiving sorafenib) Hand-foot syndrome Pruritus (itchiness) Erythema Increased amylase Increased lipase Fatigue Pain Nausea Vomiting Common (1-10% frequency) Leucopenia Neutropoenia Anaemia Thrombocytopenia Anorexia (weight loss) Hypocalcaemia Hypokalaemia Depression Peripheral sensory neuropathy Tinnitus Congestive heart failure Myocardial infarction Myocardial ischaemia Hoarseness Constipation Stomatitis Dyspepsia Dysphagia Dry skin Exfoliative dermatitis Acne Skin desquamation Arthralgia Myalgia Kidney failure Proteinuria Erectile dysfunction Asthenia (weakness) Fever Influenza-like illness Transient increase in transaminase Uncommon (0.1-1% frequency) Folliculitis Infection Hypersensitivity reactions Hypothyroidism Hyperthyroidism Hyponatraemia Dehydration Reversible posterior leukoencephalopathy Hypertensive crisis Rhinorrhoea Interstitial lung disease-like events Gastro-oesophageal reflux disease (GORD) Pancreatitis Gastritis Gastrointestinal perforations Increase in bilirubin leading, potentially, to jaundice Cholecystitis Cholangitis Eczema Erythema multiforme Keratoacanthoma Squamous cell carcinoma Gynaecomastia (swelling of the breast tissue in men) Transient increase in blood alkaline phosphatase INR abnormal Prothrombin level abnormal bulbous skin reaction Rare (0.01-0.1% frequency) QT interval prolongation Angiooedema Anaphylactic reaction Hepatitis Radiation recall dermatitis Stevens–Johnson syndrome Leucocytoclastic vasculitis Toxic epidermal necrolysis Nephrotic syndrome Rhabdomyolysis History Renal cancer Sorafenib was approved by the U.S. Food and Drug Administration (FDA) in December 2005, and received European Commission marketing authorization in July 2006, both for use in the treatment of advanced renal cancer. Liver cancer The European Commission granted marketing authorization to the drug for the treatment of patients with hepatocellular carcinoma(HCC), the most