GlaxoSmithKline has been granted marketing authorisation by the European Medicines Agency for Tafinlar® (dabrafenib) in monotherapy for the treatment of adult patients with melanoma that cannot be removed by surgery (unresectable) or that has spread to other parts of the body (metastatic) with a mutated BRAF protein.
Melanoma is the most serious type of skin cancer and causes 75-80% of skin cancer-related deaths. In the UK, melanoma affects about 12,800 people each year
The number of people getting melanoma now is more than four times higher than it was 30 years ago, and the incidence is steadily rising with age.
“Dabrafenib represents an important advance in the treatment of advanced BRAF mutation positive melanoma and for the first time gives patients and their clinicians a choice of treatment options” said Dr Paul Nathan, Consultant Medical Oncologist at Mount Vernon Cancer Centre.
If found early and confined to the skin, melanoma can usually be removed with surgery, but sometimes melanoma can spread to other parts of the body; a process referred to as metastasis.5 If melanoma metastasises, it becomes more difficult to treat and can be fatal.
Approximately 20% of primary melanomas will progress to metastatic disease. In the UK, there are approximately 2,000 new cases of metastatic melanoma per year and about 50% of these patients have the BRAF V600 mutation.
Very poor quality of life
“Melanoma is a debilitating disease and the quality of life for patients, especially those with metastatic progression, can be very poor indeed. Melanoma UK welcomes any clinical development offering metastatic melanoma patients new options against their disease” said Gill Nuttall, CEO and founder of Melanoma UK (formerly Factor 50). Abrafenib, an orally bioavailable BRAF inhibitor, is licensed to treat BRAF V600 mutation-positive metastatic melanoma.
Dabrafenib targets BRAF, a key component of the MAPK intracellular signalling pathway, which regulates the normal growth and death of cells, including skin cells. In many types of melanoma, a mutated BRAF protein on the mitogen-activated protein kinase (MAPK) pathway disrupts normal cellular regulation and promotes increased cell replication. Dabrafenib binds to the mutated BRAF protein, which may lead to an inhibition of oncogenic signaling – intracellular mechanisms that encourage cancer development – thus inhibiting the proliferation of cancer cells.
GSK says they will be working with the relevant bodies in the UK to ensure that eligible metastatic melanoma patients in England, Wales, Scotland and Northern Ireland are granted access to dabrafenib.