GlaxoSmithKline (GSK) Gets Speedy EU Review for Melanoma Drug
2/12/2013 7:47:29 AM
Recently, GlaxoSmithKline ( GSK ) announced that it has submitted a regulatory application for its oncology candidate, trametinib, as a monotherapy, for the BRAF V600 mutation-positive metastatic melanoma indication to the European Medicines Agency (EMA). The company is also looking to get trametinib in combination with another oncology candidate, dabrafenib, approved for use in adults with BRAF V600 mutation-positive metastatic melanoma. Glaxo's application seeking approval of trametinib as a monotherapy as well as combination therapy has been granted accelerated assessment by EMA's Committee for Medicinal Products for Human Use (CHMP). A final decision by the European Commission (EC) is expected by mid-Jul 2013. Glaxo submitted the marketing application primarily on the basis of encouraging data from a phase III study of trametinib as a single agent. The trial evaluated the use of trametinib versus dacarbazine or paclitaxel monotherapy in BRAF V600 mutation positive metastatic melanoma patients.