Nexavar

sorafenib

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This is a summary of the European public assessment report (EPAR) for Nexavar. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nexavar.

What is Nexavar?

Nexavar is a medicine that contains the active substance sorafenib. It is available as red, round tablets (200 mg).

What is Nexavar used for?

Nexavar is used to treat patients who have the following diseases:

  • hepatocellular carcinoma (a type of liver cancer);
  • advanced renal-cell carcinoma (a type of kidney cancer) when anticancer treatment with interferon alfa or interleukin 2 has failed or cannot be used.

Because the numbers of patients with hepatocellular carcinoma and renal-cell carcinoma are low, the diseases are considered ‘rare’, and Nexavar was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 11 April 2006 and on 29 July 2004.

The medicine can only be obtained with a prescription.

How is Nexavar used?

Treatment with Nexavar should be supervised by doctors who have experience of anticancer treatments.

Nexavar is given as two tablets twice a day, without food or with a meal that is low in fat. The treatment is continued as long as the patient continues to benefit from it without too many side effects.

How does Nexavar work?

The active substance in Nexavar, sorafenib, is a protein-kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases. These enzymes can be found in some receptors on the surface of cancer cells, where they are involved in the growth and spread of cancer cells, and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels. By blocking these enzymes, Nexavar can reduce the growth of cancer cells and cut off the blood supply that keeps cancer cells growing.

How has Nexavar been studied?

Nexavar has been compared with placebo (a dummy treatment) in two main studies. The first study involved 602 patients with hepatocellular carcinoma and the second involved 903 patients with advanced renal-cell carcinoma in whom one previous anticancer treatment had stopped working. The main measure of effectiveness in the hepatocellular carcinoma study was how long the patients survived. The main measures of effectiveness in the advanced renal cell carcinoma study were how long the patients survived and how long the patients lived without their disease getting worse.

What benefit has Nexavar shown during the studies?

Nexavar was more effective than placebo in increasing how long the patients survived.

In the study of hepatocellular carcinoma, the patients taking Nexavar survived for an average of 10.7 months, compared with 7.9 months in those taking placebo.

In the study of renal-cell carcinoma, the patients taking Nexavar survived for an average of 19.3 months, compared with 15.9 months in those taking placebo. This finding was based on the results from all 903 patients, including about 200 who had switched from placebo to Nexavar before the end of the study. The patients taking Nexavar lived for longer without their disease getting worse (167 days, around five and a half months) than those who took placebo (84 days, around three months). This finding was based on the results from 769 patients.

What is the risk associated with Nexavar?

In studies, the most common side effects with Nexavar (seen in more than 1 patient in 10) were lymphopenia (low levels of lymphocytes, a type of white blood cell), hypophosphataemia (low levels of phosphate in the blood), haemorrhage (bleeding), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, rash, alopecia (hair loss), ‘hand-foot syndrome’ (rash and pain on the palms of the hands and soles of the feet), erythema (redness), pruritus (itchiness), fatigue (tiredness), pain, and increased levels of amylase and lipase (enzymes produced by the pancreas). For the full list of all side effects reported with Nexavar, see the package leaflet.

Nexavar should not be used in people who may be hypersensitive (allergic) to sorafenib or any of the other ingredients.

Why has Nexavar been approved?

The CHMP decided that Nexavar’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Nexavar

The European Commission granted a marketing authorisation valid throughout the European Union for Nexavar on 19 July 2006. The marketing-authorisation holder is Bayer Pharma AG. The marketing authorisation is valid for an unlimited period.

For more information about treatment with Nexavar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Nexavar : EPAR - Summary for the public BG = bălgarski 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public ES = español 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public CS = čeština 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public DA = dansk 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public DE = Deutsch 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public ET = eesti keel 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public EL = elliniká 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public EN = English 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public FR = français 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public IT = italiano 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public LV = latviešu valoda 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public LT = lietuvių kalba 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public HU = magyar 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public MT = Malti 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public NL = Nederlands 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public PL = polski 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public PT = português 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public RO = română 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public SK = slovenčina 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public SL = slovenščina 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public FI = suomi 18/05/2009 25/08/2011
Nexavar : EPAR - Summary for the public SV = svenska 18/05/2009 25/08/2011

This EPAR was last updated on 27/02/2014 .

Authorisation details

Product details

Product details for Nexavar
NameNexavar
Agency product numberEMEA/H/C/000690
Active substance

sorafenib

International non-proprietary name (INN) or common name

sorafenib

Therapeutic area Carcinoma, Renal CellCarcinoma, Hepatocellular
Anatomical therapeutic chemical (ATC) code L01XE05
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Nexavar
Marketing-authorisation holder

Bayer Pharma AG

Revision23
Date of issue of marketing authorisation valid throughout the European Union19/07/2006

Contact address:

Bayer Pharma AG
13342 Berlin
Germany

Product information

Product information

31/01/2014  Nexavar -EMEA/H/C/000690 -N/0036

Name Language First published Last updated
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014
Nexavar : EPAR - Product Information SV = svenska 21/12/2009 27/02/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  
Nexavar : EPAR - All Authorised presentations SV = svenska 04/03/2007  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Hepatocellular carcinoma

Nexavar is indicated for the treatment of hepatocellular carcinoma.

Renal-cell carcinoma

Nexavar is indicated for the treatment of patients with advanced renal-cell carcinoma who have failed prior interferon-alpha- or interleukin-2-based therapy or are considered unsuitable for such therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nexavar : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 01/12/2009 27/02/2014
Nexavar-H-C-690-II-05 : EPAR - Scientific Discussion - Variation SV = svenska 17/12/2007  

Initial marketing-authorisation documents

Name Language First published Last updated
Nexavar : EPAR - Procedural steps taken before authorisation SV = svenska 04/03/2007  
Nexavar : EPAR - Scientific Discussion SV = svenska 04/03/2007  

Authorised

This medicine is approved for use in the European Union