The FDA has two new drugs in its queue this morning after GlaxoSmithKline (NYSE:GSK) submitted two new melanoma treatments, dabrafenib and trametinib, to the U.S. drug agency. GSK also submitted dabrafenib to the EU for regulatory insight, and will seek EU submission of trametinib later this year. Trials have shown significant benefit using the drugs as monotherapies, with better results than standard chemotherapy treatments, and GSK plans to test the drugs as a combination treatment. Analysts believe that a combination of the drugs could become the industry standard by 2014.
GSK is up this morning on the news, and may continue to rise as the day unfolds. The filing is only the beginning of the long waiting process with the regulatory bodies and will culminate in a PDUFA date for GSK sometime late next year. Watch for a run-up in mid-2013 if the drugs continue to do well under panel oversight.