Good news for people with melanomas that have spread—the U.S. Food and Drug Administration just approved two new drugs that target tumors with common mutations. The drugs are dabrafenib (Tafinlar), a BRAF inhibitor, and trametinib (Mekinist), an MEK inhibitor. Developed by the pharmaceutical firm GlaxoSmithKline, both drugs target BRAF V600E mutations, which occur in about half of melanoma tumors. In addition, trametinib also targets V600K mutations, which are the next most common BRAF abnormalities. While these drugs have been tested in combination, using them together is not yet approved. The FDA also okayed a new test for the BRAF V600E mutation that is made by diagnostics firm bioMerieux.
The European Medicines Agency has granted a speedy review of trametinib, an experimental MEK inhibitor made by pharmaceutical company GlaxoSmithKline. The firm’s application for a European license includes findings from two studies of melanomas that have BRAF V600 mutations: a phase III trial comparing trametinib to two standard chemotherapy drugs (dacarbazine and paclitaxel) and a phase I/II trial comparing trametinib alone and in combination with the experimental BRAF-inhibitor dabrafenib. If approved, trametinib could be available to people with melanoma within 6 months.