This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2013
  • /
  • 09
  • /
  • EU approves Tafinlar for BRAF V600 Metastatic Mela...
Drug news

EU approves Tafinlar for BRAF V600 Metastatic Melanoma

Read time: 1 mins
Last updated:3rd Sep 2013
Published:3rd Sep 2013
Source: Pharmawand

The European Commission has granted marketing authorisation for Tafinlar (dabrafenib), from Glaxo Smith Kline, as an oral targeted treatment indicated in monotherapy for unresectable Melanoma or Metastatic Melanoma in adults with a BRAF V600 mutation. Approval is based on results from several multicentre global trials. In one trial, a Phase III BREAK-3 study, the drug reduced the relative risk of disease progression or death by 70% compared to dacarbazine (p<0.0001).>

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 (p<0.0001). the data showed a median progression free survival of 6.9 months compared to 2.7 months for dacarbazine. dabrafenib is also licensed in the u.s, canada and australia.>

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.