What is Zelboraf - Vemurafenib?
Zelboraf is a medicine that contains the active substance vemurafenib. It is available as tablets (240 mg).
What is Zelboraf - Vemurafenib 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 is not operable. It is only indicated for patients whose tumor cell genes show a mutation. BRAF V600.
The medicine can only be obtained with a prescription.
How is Zelboraf used?
Treatment with Zelboraf should be initiated and supervised by a specialist experienced in cancer therapy. Before starting it, the presence of the BRAF V600 mutation in the cancer cells of the patients must be ascertained.
The recommended dose is 960 mg (four tablets) twice a day. The first dose is taken in the morning and the second dose in the evening, approximately 12 hours later. Each dose should always be taken in the same way, during meals or between meals.
Treatment should be continued as long as possible until the disease gets worse or the side effects become too severe.
How does Zelboraf - Vemurafenib work?
The active substance in Zelboraf, vemurafenib, is an inhibitor of BRAF, a protein that participates in the stimulation of cell division. An abnormal form of BRAF is present in melanomas with the BRAF V600 mutation which contributes to tumor development by allowing the uncontrolled division of cancer cells. By blocking the action of the abnormal BRAF protein, Zelboraf helps slow the growth and spread of the tumor. Zelboraf is only given to patients with melanomas caused by a BRAF V600 mutation.
How has Zelboraf - Vemurafenib 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 one main study involving 675 patients with melanoma containing the diffuse or inoperable BRAF V600 mutation. Patients were to receive the medicine until the disease got worse or the treatment developed an excessive level of toxicity. The main measures of efficacy were overall survival and progression-free survival of the disease.
What benefits has Zelboraf shown during the studies?
Zelboraf has been shown to be effective in prolonging the life of patients and delaying the worsening of the disease. As evidenced by the main study, survival for patients treated with Zelboraf averaged 13.2 months, compared with 9.6 months for patients treated with dacarbazine. As for the worsening of the disease, in the Zelboraf group it occurred on average after 5.3 months, compared with 1.6 months in the dacarbazine group.
What is the risk associated with Zelboraf?
The most common side effects of Zelboraf (seen in more than 30% of patients) include arthralgia (joint pain), fatigue, rash, photosensitive reactions (sunburn-like reactions caused by exposure to light), nausea, alopecia (hair loss ) and itching. Some of the patients treated with Zelboraf develop another type of skin cancer called "squamous cell skin cancer" which can be effectively treated with local surgery. For the full list of side effects reported with Zelboraf, see the package leaflet.
Zelboraf must not be used in people who may be hypersensitive (allergic) to vemurafenib or any of the other ingredients.
Why has Zelboraf - Vemurafenib been approved?
The CHMP noted that the efficacy of Zelboraf in improving overall survival and delaying the worsening of widespread or inoperable "BRAF V600 mutation positive" melanoma had been convincingly demonstrated. Regarding the risks, about half of the patients treated with Zelboraf developed a serious side effect and around one fifth developed skin squamous cell carcinoma. The CHMP considered the side effects manageable and included recommendations to doctors to help reduce the risks in the product information. concluded that the benefits of Zelboraf outweigh its risks and recommended that it be given a marketing authorization for the medicine.
Other information about Zelboraf - Vemurafenib
On February 17, 2012, the European Commission issued a "marketing authorization" for Zelboraf, valid throughout the European Union.
For more information about Zelboraf therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 01-2012.
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