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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

"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."

Melanoma is the most serious type of skin cancer, which causes about 75%-80% of skin cancer-related deaths.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.