The European Medicines Agency (EMA) has given marketing authorisation to GlaxoSmithKline (GSK) Tafinlar drug for the treatment of melanoma in adult patients.
The drug, also known as Dabrafenib, specifically treats melanoma that cannot be removed by surgery, unresectable, or that has spread to other parts of the body, metastatic, with a mutated BRAF protein, specifically the BRAF V600 genetic mutation.
Melanoma, the most serious type of skin cancer, affects an estimated 12,800 people each year and is disproportionately high in younger people. It causes 75%-80% of skin cancer-related deaths.
Approximately 20% of primary melanomas will progress to metastatic disease.
The UK’s Mount Vernon Cancer Centre consultant medical oncologist Dr Paul Nathan said: "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"
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 disrupts normal cellular regulation and promotes increased cell replication.
Dabrafenib binds to the mutated BRAF protein and inhibits the proliferation of cancer cells.
GSK UK’s general manager Erik van Snippenberg said: "Dabrafenib is the first licensed medicine of a new wave of cancer treatments currently being developed by GSK.
"The authorisation of dabrafenib increases the therapeutic alternatives for this disease and is an important development for metastatic melanoma patients who, until recently, had very few options available."
The EMA’s authorisation of Dabrafenib is based on a Phase III BREAK-3 study, where the primary objective (endpoint) of the study was the relative proportion of patients who were alive and free from disease progression following treatment with dabrafenib versus dacarbazine (chemotherapy).
The median progressive free survival by the cut of date of December 2011 was 5.1 months with dabrafenib compared with 2.7 months with dacarbazine. Later analysis showed that progression free survival after the cut off date was even longer.
Image: GSK’s headquarters in the UK. Photo: courtesy of Maxwell Hamilton.