GSK files at EMA trametinib (monotherapy) and in combination with dabrafenib for Metastatic Melanoma

GSK announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for trametinib (MEK) as monotherapy and in combination with dabrafenib (BRAF) for the treatment of adult patients with unresectable or Metastatic Melanoma with a BRAF V600 mutation. The EMA�s Committee for Medicinal Products for Human Use (CHMP) has granted GSK�s request for accelerated assessment of this application.

The application includes data from a randomised, Phase III study of trametinib monotherapy compared to dacarbazine or paclitaxel monotherapy in patients with BRAF V600 mutation positive metastatic melanoma, as well as data from a randomised Phase I/II study comparing dabrafenib monotherapy to combination therapy with dabrafenib and trametinib in patients with BRAF V600 mutation positive Metastatic Melanoma.