GlaxoSmithKline, the world’s leading research-based pharmaceutical and healthcare companies, has received marketing authorisation from the European Commission for Tafinlar (dabrafenib) as an oral targeted treatment indicated in monotherapy for unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) in adult patients with a BRAF V600 mutation.

Dabrafenib is not indicated for the treatment of patients with wild-type BRAF melanoma. Before taking dabrafenib, patients must have confirmation of a BRAF V600 mutation using a validated test.

“Today’s authorisation of Tafinlar™ represents an important step in GSK's ongoing effort to bring new treatment options to cancer patients, especially as we have brought it to market in less than five years after our initial testing,” said Paolo Paoletti, M.D., President, GlaxoSmithKline Oncology. “With this new personalised medicine, we hope to make a meaningful difference in the lives of appropriate patients with metastatic melanoma; a devastating disease and a cancer with one of the lowest survival rates.”

Dabrafenib is a kinase inhibitor that targets BRAF, a key component of a biological pathway in the body that regulates the normal growth and death of cells, including skin cells. The availability of a diagnostic test allows the identification of patients with unresectable or metastatic melanoma who have the BRAF V600 mutation, and therefore are eligible to receive this therapy.

Melanoma is the most serious type of skin cancer and causes 75 per cent of skin cancer-related deaths. If found early and confined to the skin, melanoma can usually be removed with surgery, but sometimes it can spread to other parts of the body, a process referred to as metastasis.4 Typically, less than five per cent of all newly incident melanoma patients present with metastatic disease. A BRAF gene mutation is seen in 50-70 per cent of cutaneous melanoma cases.

The marketing authorisation for dabrafenib is based on results from several multicentre global trials. One of these trials was a phase III study, BREAK-3, in which treatment with dabrafenib was compared to dacarbazine (chemotherapy) in 250 previously untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma. At the pre-specified analysis of BREAK-3, from December 2011, dabrafenib reduced the relative risk of disease progression or death by 70 per cent compared to dacarbazine (95 per cent CI: 0.18, 0.51, p<0.0001). Study data showed a median progression-free survival of 5.1 months with dabrafenib (95 per cent CI; 4.9, 6.9) compared to 2.7 months for dacarbazine (95 per cent CI: 1.5, 3.2) (2011 cut-off data).

In a post-hoc analysis from June 2012, dabrafenib reduced the relative risk of disease progression or death by 63 per cent compared to dacarbazine (95 per cent CI: 0.24, 0.58, P<0.0001). The data showed a median progression free survival of 6.9 months (95 per cent CI: 5.2, 9.0) compared to 2.7 months for dacarbazine (95 per cent CI: 1.5, 3.2). A further post-hoc analysis, from December 2012, showed overall survival at 12 months was 70 per cent with dabrafenib, compared with 63 per cent for dacarbazine (HR = 0.76, 95 per cent CI: 0.48, 1.21).1

Patients with melanoma driven by BRAF mutations other than V600E were excluded from the BREAK-3 trial and with respect to patients with the V600K mutation in single arm studies, the activity appears lower than in V600E tumours.

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