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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/670247/2015

EMEA/H/C/002604

EPAR summary for the public

Tafinlar

dabrafenib

This is a summary of the European public assessment report (EPAR) for Tafinlar. It explains how the Agency assessed the medicine to recommend its authorisation in the 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).

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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.

The full EPAR for Tafinlar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Tafinlar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2015.

Tafinlar

EMA/670247/2015

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