GSK’s melanoma drug approved in Europe

The European Commission has granted marketing authorization to GSK's metastatic melanoma treatment, Tafinlar.

Tafinlar (dabrafenib) is an oral targeted treatment indicated in monotherapy for unresectable melanoma or metastatic melanoma in adult patients with a BRAF V600 mutation.

"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. 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."

Paolo Paoletti, M.D., President, GlaxoSmithKline Oncology.

Melanoma is the most serious type of skin cancer and causes 75% of skin cancer-related deaths. Over 200,000 people worldwide were diagnosed with melanoma in 2008 and this figure is predicted to reach 233,000 by 2015, according to the World Health Organisation. A BRAF gene mutation is seen in 50-70% of cutaneous melanoma cases.

Tafinlar was recently approved for use in the United States by the Food and Drug Administration, alongside GSK's other melanoma drug, Mekinist. Mekinist (trametinib) is a MEK inhibitor, approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations.

Related news:

Tafinlar now approved for metastatic melanoma in Europe (The Pharma Letter)

Reference links:

GSK press release