Zelboraf

vemurafenib

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About

An overview of Zelboraf and why it is authorised in the EU

Zelboraf is a cancer medicine 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 (genetic change) called ‘BRAF V600’.

Zelboraf contains the active substance vemurafenib.

How is Zelboraf used?

Zelboraf can only be obtained with a prescription and treatment 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.

Zelboraf is available as tablets (240 mg). 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 until the disease worsens or the side effects become too severe.

For more information about using Zelboraf, see the package leaflet or contact your doctor or pharmacist.

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.

What benefits of Zelboraf have been shown in studies?

Zelboraf was compared with the cancer 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 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).

Zelboraf was shown to be effective at prolonging patients’ lives and delaying the worsening of the disease. The 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 are the risks associated with Zelboraf?

The most common side effects with Zelboraf (which may affect more than 3 in 10 patients) include arthralgia (joint pain), tiredness, rash, photosensitivity reaction (sunburn-like reactions following exposure to light), nausea and vomiting (feeling sick and being sick), alopecia (hair loss), diarrhoea, headache, pruritus (itching), skin papilloma (warts) and hyperkeratosis (thickening and toughening of the skin). The most common serious side effects include another type of skin cancer called ‘cutaneous squamous cell carcinoma’, which is commonly treated by local surgery, keratoacanthoma (benign skin tumour), rash, arthralgia and change in liver test results (increased gamma-glutamyltransferase [GGT]).

For the full list of side effects and restrictions with Zelboraf, see the package leaflet.

Why is Zelboraf authorised in the EU?

The European Medicines Agency decided that Zelboraf’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency noted that Zelboraf had been convincingly shown to improve overall survival and to delay the worsening of ‘BRAF V600 positive’ melanoma which has spread or cannot be surgically removed. With regard to its risks, in the main study around half of the patients taking Zelboraf experienced a severe side effect and about one fifth developed cutaneous squamous cell carcinoma. The Agency considered the side effects to be manageable and included recommendations for doctors to help reduce the risks in the product information.

What measures are being taken to ensure the safe and effective use of Zelboraf?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zelboraf have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Zelboraf are continuously monitored. Side effects reported with Zelboraf are carefully evaluated and any necessary action taken to protect patients.

Other information about Zelboraf

Zelboraf received a marketing authorisation valid throughout the EU on 17 February 2012.

Name Language First published Last updated
Zelboraf : EPAR - Summary for the public BG = bălgarski 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public ES = español 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public CS = čeština 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public DA = dansk 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public DE = Deutsch 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public ET = eesti keel 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public EL = elliniká 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public EN = English 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public FR = français 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public IT = italiano 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public LV = latviešu valoda 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public LT = lietuvių kalba 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public HU = magyar 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public MT = Malti 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public NL = Nederlands 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public PL = polski 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public PT = português 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public RO = română 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public SK = slovenčina 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public SL = slovenščina 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public FI = suomi 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public SV = svenska 2012-03-19 2018-04-12
Zelboraf : EPAR - Summary for the public HR = Hrvatski 2012-03-19 2018-04-12

This EPAR was last updated on 12/04/2018 .

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

Publication details

Publication details for Zelboraf
Marketing-authorisation holder

Roche Registration GmbH

Revision17
Date of issue of marketing authorisation valid throughout the European Union17/02/2012

Contact address:

Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

Product information

06/04/2018  Zelboraf -EMEA/H/C/002409 -T/0047

Name Language First published Last updated
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12
Zelboraf : EPAR - Product Information HR = Hrvatski 2012-03-19 2018-04-12

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 HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27
Zelboraf : EPAR - All Authorised presentations HR = Hrvatski 2012-03-19 2013-06-27

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

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union

More information on Zelboraf