Drug

BRAFTOVI®

Encorafenib

Braftovi Overview

Braftovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.

Braftovi is used in combination with another medicine, binimetinib (Mektovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called ‘BRAF V600’.

It contains the active substance encorafenib.

Braftovi is available as capsules (50 mg and 75 mg). Patients normally take 450 mg (six 75 mg capsules) once a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects. The dose of the other medicine, binimetinib, may also be reduced but if binimetinib is stopped Braftovi must be stopped too.

Treatment with Braftovi can last for as long as the patient is benefiting from it and does not have unacceptable side effects.

Braftovi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in prescribing cancer medicines. For more information about using Braftovi, see the package leaflet or contact your doctor or pharmacist

In melanoma tumours with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division. This encourages cancers to develop by allowing uncontrolled division of cells. The active substance in Braftovi, encorafenib, works by blocking the BRAF protein thereby stopping its activation by MEK and slowing down the growth and spread of the cancer.

A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Braftovi with binimetinib can prolong the length of time patients lived without their disease getting worse.

Patients who took this combination lived on average for nearly 15 months without the disease getting worse. This compared with over 9.5 months for patients who took encorafenib alone and just over 7 months for patients taking a different medicine called vemurafenib.

Up to 50% of patients with metastatic melanoma have a mutation in BRAF with the V600 mutation being the most common. Braftovi in combination with binimetinib can help prolong the time that these patients live without their disease getting worse. The side effects seen with Braftovi are similar to those seen with other medicines in the same class and are considered manageable.

The European Medicines Agency therefore decided that Braftovi’s benefits are greater than its risks and it can be authorised for use in the EU.

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

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

Braftovi received a marketing authorisation valid throughout the EU on 20 September 2018.

What are the risks associated with Braftovi?

The most common side effects with Braftovi and binimetinib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems. These side effects occurred in more than 1 in 4 patients.

Owner of copyright and other intellectual property rights to European Medicines Agency

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