UK-based pharmaceutical firm GlaxoSmithKline (GSK) has received approval from the European Commission (EC) for the marketing of its Tafinlar (dabrafenib) as an oral targeted treatment.
The EU authorisation for dabrafenib was based on positive results from several multicentre global trials.
Data from BREAK-3, a Phase III study comparing dabrafenib to dacarbazine (chemotherapy) in 250 previously untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma, showed a median progression-free survival of 5.1 months with dabrafenib (95% CI; 4.9, 6.9) compared to 2.7 months for dacarbazine (95% CI: 1.5, 3.2) (2011 cut-off data).
Additionally, post-hoc analysis data, conducted from December 2012, demonstrated overall survival was 70% with dabrafenib, compared to 63% for dacarbazine at 12 months.
GSK’s Tafinlar is a monotherapy for the treatment of adult patients with melanoma that cannot be removed by surgery or that has spread to other parts of the body with a BRAF V600 mutation.
Melanoma is the most serious type of skin cancer, which causes about 75%-80% of skin cancer-related deaths.
According to GSK, Tafinlar is not indicated for the treatment of patients with wild-type BRAF melanoma and before taking it, patients must have confirmation of a BRAF V600 mutation using an authorised test.
GlaxoSmithKline Oncology president Paolo Paoletti said the authorisation of Tafinlar will strengthen the company’s ongoing effort to bring new treatment options to cancer patients.
"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," Paoletti said.
Tafinlar targets BRAF, a major component of the mitogen-activated protein kinase (MAPK) pathway, which regulates the normal growth and death of cells, including skin cells.
Currently, dabrafenib has European license for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation as detected by a validated test.