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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/53181/2012

EMEA/H/C/002409

EPAR summary for the public

Zelboraf

vemurafenib

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.

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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 which 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 in the product information recommendations 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.

Zelboraf

Other information about Zelboraf

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

The full EPAR for Zelboraf 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 Zelboraf, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2012.

Zelboraf

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