Sorafenib (Nexavar)

General information

Class/mechanism: Tyrosine kinase inhibitor that inhibits multiple kinases: RAF1, BRAF, KIT, FLT-3, RET, vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, VEGFR-3, and platelet-derived growth factor receptor beta (PDGFR-B). Inhibition of these kinases disrupts angiogenesis, tumor cell signaling, and induces apoptosis.
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Acute myeloid leukemia
• Hepatocellular carcinoma
• Non-small cell lung cancer, nonsquamous
• Osteosarcoma
• Renal cell carcinoma
  • Clear cell renal cell carcinoma
• Soft tissue sarcoma
  • Desmoid tumors
• Thyroid cancer
  • Differentiated thyroid cancer
  • Medullary thyroid cancer

Patient drug information

• Sorafenib (Nexavar) package insert
• Sorafenib (Nexavar) patient drug information (Chemocare)
• Sorafenib (Nexavar) patient drug information (UpToDate)

History of changes in FDA indication

• 12/20/2005: FDA approved "for the treatment of patients with advanced renal cell carcinoma (RCC)."
• 11/16/2007: FDA approved "for the treatment of patients with unresectable hepatocellular carcinoma (HCC)."
• 11/22/2013: FDA approved "for the treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment"

History of changes in EMA indication

• 7/19/2006: Initial marketing authorization as Nexavar

Also known as

• Code names: BAY 43-9006, BAY 54-9085
• Brand names: Nexavar, Sorafenat, Soranib