On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.1,2 Approval of the combination is based on durable response rate observed in an open-label study.2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.
Click on the PDF icon at the top of this introduction to read the full article.