Sorafenib

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Sorafenib
Clinical data
SynonymsNexavar
Sorafenib tosylate
[[Regulation of therapeutic goods |Template:Engvar data]]
Pregnancy
category
  • AU: D
  • US: D (Evidence of risk)
Routes of
administration
Oral
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability29-49%
Protein binding99.5%
MetabolismHepatic oxidation and glucuronidation (CYP3A4-mediated)
Elimination half-life25–48 hours
ExcretionFecal (77%) and renal (19%)
Identifiers
CAS Number
PubChem CID
DrugBank
E number{{#property:P628}}
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Chemical and physical data
FormulaC21H16ClF3N4O3
Molar mass464.825 g/mol
3D model (JSmol)

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Overview

Sorafenib (rINN), marketed as Nexavar by Bayer, is a drug approved for the treatment of advanced renal cell carcinoma (primary kidney cancer). It has also received "Fast Track" designation by the FDA[1] for the treatment of advanced hepatocellular carcinoma (primary liver cancer), and has since performed well in Phase III trials[2].

Pharmacology

It is a small molecular inhibitor of Raf kinase, PDGF (platelet-derived growth factor), VEGF receptor 2 & 3 kinases and c Kit the receptor for Stem cell factor. A growing number of drugs target most of these pathways. The originality of Sorafenib lays in its simultaneous targeting of the Raf/Mek/Erk pathway.[3]

Approval

Sorafenib was approved by the U.S. Food and Drug Administration (FDA) on December 20, 2005 and received a E.U. marketing authorisation on July 19, 2006[4].

The European Commission has granted marketing authorization to Nexavar® (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, on October 30, 2007. [5].

Studies

A New England Journal of Medicine article published in January 2007 showed compared with placebo, treatment with sorafenib prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed; the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group (hazard ratio for disease progression in the sorafenib group, 0.44; 95% confidence interval [CI], 0.35 to 0.55; P<0.01). The first interim analysis of overall survival in May 2005 showed that sorafenib reduced the risk of death, as compared with placebo (hazard ratio, 0.72; 95% CI, 0.54 to 0.94; P=0.02), although this benefit was not statistically significant according to the O'Brien–Fleming threshold. Partial responses were reported as the best response in 10% of patients receiving sorafenib and in 2% of those receiving placebo (P<0.001).

At ASCO 2007, results from the SHARP trial were presented, which showed efficacy of sorafenib in hepatocellular carcinoma. The primary endpoint was overall survival, which showed a 44% improvement in patients who received sorafenib compared to placebo (hazard ratio 0.69; 95% CI, 0.55 to 0.87; p=0.0001). Both median survival and time to progression showed 3-month improvements.

Regulatory filing is planned.

Side effects

Side effects of sorafenib included skin rash, hand-foot skin reactions, diarrhea, and hypertension.

Footnotes

  1. https://lnn605.aus.us.siteprotect.com/medicalnews.php?newsid=45119
  2. http://www.healthtech.com/news/top_news/2007/June/Nexavar_Extends_Survival.asp
  3. "SorafenibSunitinibdifferences". Retrieved 2007-08-15.
  4. European Commission - Enterprise and industry. Nexavar. Retrieved April 24,2007.
  5. DGnews [1]. Retrieved November 02, 2007.

External links

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