What is Tafinlar - dabrafenib used for?
Tafinlar is a cancer medicine that contains the active substance dabrafenib . It is used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or is inoperable. Tafinlar is indicated only for patients in whom the presence in the genes of melanoma tumor cells of a specific mutation (variation) called "BRAF V600" has been ascertained by a test.
How is Tafinlar used - dabrafenib?
Treatment with Tafinlar should 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 mg and 75 mg). It is given at the recommended dose of 150 mg twice a day, taken at least one hour before a meal or at least two hours after a meal. The treatment should be continued for as long as possible, until the disease gets worse or until the side effects become too severe. If the patient complains of some side effects it may be necessary to suspend or stop the therapy or reduce the dose. For more information, see the summary of product characteristics (also part of the EPAR).
How does Tafinlar - dabrafenib work?
The active ingredient in Tafinlar, dabrafenib, works by blocking BRAF, a protein that is involved in stimulating cell division. In the BRAF V600 mutation melanomas there is an abnormal form of BRAF that contributes to tumor development, allowing the uncontrolled division of tumor cells. By blocking the action of the abnormal BRAF protein, Tafinlar helps slow the growth and spread of the tumor. Tafinlar is administered only to patients with melanomas caused by the BRAF V600 mutation.
What benefit has Tafinlar - dabrafenib shown during the studies?
Tafinlar was examined in a main study involving 250 patients with melanoma containing the BRAF V600 mutation, spread to other parts of the body or inoperable. Tafinlar was compared with the anticancer medicine dacarbazine; the main measure of effectiveness was the life span of the patients until the disease got worse (progression-free survival). In this study Tafinlar was more effective than dacarbazine in controlling the disease: in patients treated with Tafinlar, on average, 6.9 months elapsed before the disease worsened compared to 2.7 months in subjects treated with dacarbazine.
What is the risk associated with Tafinlar - dabrafenib?
The most common side effects of Tafinlar (which may affect more than 1 in 10 people) are papilloma (warts), decreased appetite, headache, cough, nausea and vomiting, diarrhea, hyperkeratosis (thickening and hardening of the skin), alopecia (hair loss), rash, hand-foot syndrome (skin reaction and numbness of the palms of the hands and soles of the feet), arthralgia and myalgia (pain affecting joints and muscles), pain in the extremities, fever, chills, fatigue and asthenia (feeling of weakness). For the full list of all side effects reported with Tafinlar, see the package leaflet
Why has Tafinlar - dabrafenib been 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 had convincingly demonstrated to offer a clinically relevant benefit to patients with BRAF V600 mutation-positive melanoma spread to other parts of the body or inoperable. Undesirable effects are considered acceptable and manageable with appropriate measures.
What measures are being taken to ensure the safe and effective use of Tafinlar - dabrafenib?
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 information sheet for Tafinlar, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Tafinlar - dabrafenib
On 26 August 2013, the European Commission issued a marketing authorization for Tafinlar, valid throughout the European Union. For more information about Tafinlar therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08-2013.
