Zelboraf

vemurafenib

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This is a summary of the European public assessment report (EPAR) for Zelboraf. 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 Zelboraf.

What is Zelboraf?

Zelboraf is a medicine that contains the active substance vemurafenib. It is available as tablets (240 mg).

What is Zelboraf used for?

Zelboraf is used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed. Zelboraf is only for patients whose melanoma tumour cells have a specific mutation called ‘BRAF V600’ in their genes.

The medicine can only be obtained with a prescription.

How is Zelboraf used?

Treatment with Zelboraf should be started and supervised by a specialist doctor experienced in treating cancer. Before starting treatment a test must be carried out to make sure that the patient’s tumours have the BRAF V600 mutation.

The recommended dose is 960 mg (four tablets) twice daily. The first dose is taken in the morning and the second dose in the evening around 12 hours later. Each dose can be taken with or without food, but Zelboraf should be taken in the same way day to day.

Treatment should be continued for as long as possible, until the disease worsens or the side effects become too severe.

How does Zelboraf work?

The active substance in Zelboraf, vemurafenib, is an inhibitor of BRAF, a protein involved in stimulating cell division. In melanoma tumours with the BRAF V600 mutation, an abnormal form of BRAF is present which plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells. By blocking the action of the abnormal BRAF, Zelboraf helps to slow down the growth and spread of the cancer. Zelboraf is only given to patients whose melanoma tumours are caused by the BRAF V600 mutation.

How has Zelboraf been studied?

The effects of Zelboraf were first tested in experimental models before being studied in humans.

Zelboraf was compared with the anticancer medicine dacarbazine in a main study involving 675 patients with melanoma containing the BRAF V600 mutation whose tumours had spread or could not be surgically removed. Patients were to receive either medicine for as long as they could until their disease got worse or their treatment became too toxic for them. The main measures of effectiveness were how long the patients lived (overall survival) and how long they lived without their disease getting worse (progression-free survival).

What benefit has Zelboraf shown during the studies?

Zelboraf was shown to be effective at prolonging patients’ lives and delaying the worsening of the disease. The main study showed that patients taking Zelboraf lived on average for 13.2 months compared with 9.9 months for patients on dacarbazine, and it took on average 5.3 months for the disease to worsen in the Zelboraf group compared with 1.6 months in the dacarbazine group.

What is the risk associated with Zelboraf?

The most common side effects with Zelboraf (seen in more than 30% of patients) include arthralgia (joint pain), fatigue (tiredness), rash, photosensitivity reaction (sunburn-like reactions following exposure to light), nausea (feeling sick), alopecia (hair loss) and pruritus (itching). Some patients treated with Zelboraf develop another type of skin cancer called ‘cutaneous squamous-cell carcinoma’ which is successfully treated by local surgery. For the full list of all side effects reported with Zelboraf, see the package leaflet.

Zelboraf must not be used in people who are hypersensitive (allergic) to vemurafenib or any of the other ingredients.

Why has Zelboraf been approved?

The CHMP noted that Zelboraf had been convincingly shown to improve overall survival and to delay the worsening of ‘BRAF-V600-positive’ melanoma that has spread or cannot be surgically removed. With regard to its risks, around half of the patients taking Zelboraf experienced a severe side effect and about one fifth developed cutaneous squamous-cell carcinoma. The CHMP considered the side effects to be manageable and included recommendations in the product information for doctors to help reduce the risks. The Committee concluded that benefits of Zelboraf are greater than its risks and recommended that it be granted marketing authorisation.

Other information about Zelboraf

The European Commission granted a marketing authorisation valid throughout the European Union for Zelboraf on 17 February 2012.

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

Name Language First published Last updated
Zelboraf : EPAR - Summary for the public BG = bălgarski 19/03/2012  
Zelboraf : EPAR - Summary for the public ES = español 19/03/2012  
Zelboraf : EPAR - Summary for the public CS = čeština 19/03/2012  
Zelboraf : EPAR - Summary for the public DA = dansk 19/03/2012  
Zelboraf : EPAR - Summary for the public DE = Deutsch 19/03/2012  
Zelboraf : EPAR - Summary for the public ET = eesti keel 19/03/2012  
Zelboraf : EPAR - Summary for the public EL = elliniká 19/03/2012  
Zelboraf : EPAR - Summary for the public EN = English 19/03/2012  
Zelboraf : EPAR - Summary for the public FR = français 19/03/2012  
Zelboraf : EPAR - Summary for the public IT = italiano 19/03/2012  
Zelboraf : EPAR - Summary for the public LV = latviešu valoda 19/03/2012  
Zelboraf : EPAR - Summary for the public LT = lietuvių kalba 19/03/2012  
Zelboraf : EPAR - Summary for the public HU = magyar 19/03/2012  
Zelboraf : EPAR - Summary for the public MT = Malti 19/03/2012  
Zelboraf : EPAR - Summary for the public NL = Nederlands 19/03/2012  
Zelboraf : EPAR - Summary for the public PL = polski 19/03/2012  
Zelboraf : EPAR - Summary for the public PT = português 19/03/2012  
Zelboraf : EPAR - Summary for the public RO = română 19/03/2012  
Zelboraf : EPAR - Summary for the public SK = slovenčina 19/03/2012  
Zelboraf : EPAR - Summary for the public SL = slovenščina 19/03/2012  
Zelboraf : EPAR - Summary for the public FI = suomi 19/03/2012  
Zelboraf : EPAR - Summary for the public SV = svenska 19/03/2012  

This EPAR was last updated on 07/04/2014 .

Authorisation details

Product details

Product details for Zelboraf
NameZelboraf
Agency product numberEMEA/H/C/002409
Active substance

vemurafenib

International non-proprietary name (INN) or common name

vemurafenib

Therapeutic area Melanoma
Anatomical therapeutic chemical (ATC) code L01XE15
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Zelboraf
Marketing-authorisation holder

Roche Registration Ltd.

Revision7
Date of issue of marketing authorisation valid throughout the European Union17/02/2012

Contact address:

Roche Registration Ltd.
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Product information

Product information

20/02/2014  Zelboraf -EMEA/H/C/002409 -II/0014

Name Language First published Last updated
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014
Zelboraf : EPAR - Product Information SV = svenska 19/03/2012 10/02/2014

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
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013
Zelboraf : EPAR - All Authorised presentations SV = svenska 19/03/2012 27/06/2013

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zelboraf : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 25/01/2013 07/04/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Zelboraf : EPAR - Public assessment report SV = svenska 19/03/2012  
CHMP summary of positive opinion for Zelboraf SV = svenska 16/12/2011  

Authorised

This medicine is approved for use in the European Union

More information on Zelboraf