Tafinlar

dabrafenib

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This is a summary of the European public assessment report (EPAR) for Tafinlar. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Tafinlar.

For practical information about using Tafinlar, patients should read the package leaflet or contact their doctor or pharmacist.

What is Tafinlar and what is it used for?

Tafinlar is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread or cannot be surgically removed. It is used on its own or in combination with trametinib, another cancer medicine to treat melanoma.

Tafinlar is only for patients whose melanoma tumour cells have been tested and shown to have a specific genetic mutation (change) called ‘BRAF V600’.

Tafinlar contains the active substance dabrafenib.

How is Tafinlar used?

Treatment with Tafinlar must be started and supervised by a doctor experienced in the use of anticancer medicines. The medicine can only be obtained with a prescription.

Tafinlar is available as capsules (50 and 75 mg). The dose of Tafinlar either used alone or in combination with trametinib is 150 mg twice a day.

Tafinlar is taken at least one hour before or two hours after a meal. Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe. Treatment may need to be interrupted or stopped, or the dose reduced, if the patient experiences certain side effects. For further information, see the summary of product characteristics (also part of the EPAR).

How does Tafinlar work?

The active substance in Tafinlar, dabrafenib, works by blocking BRAF, a protein involved in stimulating cell division. In melanoma with the BRAF V600 mutation, the abnormal form of BRAF 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, Tafinlar helps to slow down the growth and spread of the cancer. Tafinlar is only given to patients whose melanoma is caused by the BRAF V600 mutation.

What benefits of Tafinlar have been shown in studies?

Tafinlar alone was studied in one main study involving 250 patients with melanoma that had spread to other parts of the body or could not be surgically removed, and whose melanoma had a BRAF V600 mutation. Tafinlar was compared with the cancer medicine dacarbazine, and the main measure of effectiveness was how long patients lived until their disease got worse (progression-free survival). In this study Tafinlar was more effective than dacarbazine in controlling the disease: it took on average 6.9 months before the disease got worse in patients given Tafinlar, compared with 2.7 months in patients given dacarbazine. 

In one of two studies of Tafinlar in combination with trametinib, 423 patients were given either the combination or Tafinlar alone. The result was that patients given the combination lived for 11 months without their disease worsening, while those given Tafinlar alone lived for 8.8 months without their disease worsening. In a second study involving 704 patients, Tafinlar with trametinib was compared with another medicine for melanoma, vemurafenib. Patients given the combination lived longer on average, 25.6 months versus 18 months with vemurafenib.

What are the risks associated with Tafinlar?

The most common side effects with Tafinlar alone (seen in more than 15% of patients) are papilloma (warts), headache, nausea, vomiting, hyperkeratosis (thickening and toughening of the skin), hair loss, rash, joint pain, fever and tiredness.

When Tafinlar is taken in combination with trametinib the most common side effects (seen in more than 20% of patients) are fever, tiredness, nausea, headache, chills, diarrhoea, rash, joint pain, high blood pressure, vomiting and cough.

For the full list of all side effects reported with Tafinlar see the package leaflet.

Why is Tafinlar approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Tafinlar’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that Tafinlar (alone or in combination with trametinib) had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation and had spread or was not surgically removable. The side effects were considered acceptable and manageable with appropriate measures.

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

A risk management plan has been developed to ensure that Tafinlar is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tafinlar, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Tafinlar

The European Commission granted a marketing authorisation valid throughout the European Union for Tafinlar on 26 August 2013.

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

Name Language First published Last updated
Tafinlar : EPAR - Summary for the public BG = bălgarski 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public ES = español 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public CS = čeština 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public DA = dansk 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public DE = Deutsch 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public ET = eesti keel 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public EL = elliniká 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public EN = English 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public FR = français 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public IT = italiano 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public LV = latviešu valoda 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public LT = lietuvių kalba 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public HU = magyar 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public MT = Malti 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public NL = Nederlands 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public PL = polski 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public PT = português 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public RO = română 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public SK = slovenčina 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public SL = slovenščina 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public FI = suomi 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public SV = svenska 2013-09-18 2015-11-03
Tafinlar : EPAR - Summary for the public HR = Hrvatski 2013-09-18 2015-11-03

This EPAR was last updated on 22/06/2016 .

Authorisation details

Product details

Product details for Tafinlar
NameTafinlar
Agency product numberEMEA/H/C/002604
Active substance

dabrafenib

International non-proprietary name (INN) or common name

dabrafenib

Therapeutic area Melanoma
Anatomical therapeutic chemical (ATC) code L01XE23
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 Tafinlar
Marketing-authorisation holder

Novartis Europharm Limited

Revision9
Date of issue of marketing authorisation valid throughout the European Union26/08/2013

Contact address:

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

Product information

12/05/2016  Tafinlar -EMEA/H/C/002604 -II/0019

Name Language First published Last updated
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22
Tafinlar : EPAR - Product Information HR = Hrvatski 2013-09-18 2016-06-22

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
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  
Tafinlar : EPAR - All Authorised presentations HR = Hrvatski 2013-09-18  

Pharmacotherapeutic group

Antineoplastic agents, protein

Therapeutic indication

Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Tafinlar : EPAR - Public assessment report HR = Hrvatski 2013-09-18  
CHMP summary of positive opinion for Tafinlar HR = Hrvatski 2013-06-28  

Authorised

This medicine is approved for use in the European Union