Two Melanoma Drugs Win FDA Approval

The FDA approved two new drugs for metastatic or inoperable melanoma, dabrafenib (Tafinlar) and trametinib (Mekinist). Dabrafenib is an inhibitor of the BRAF gene when it carries the so-called V600E mutation. Trametinib inhibits a target known as MEK and is effective primarily against melanomas carrying either the V600E or V600K mutations. Dabrafenib and trametinib were approved separately as stand-alone drugs, not as a combination, although therapy with both drugs together has been tested clinically and appeared to be better than dabrafenib alone. The agency also approved a companion diagnostic test for both agents to detect certain mutations in the BRAF gene that render melanoma cells susceptible to the drugs. The diagnostic product, called the THxID BRAF test, was evaluated in the same clinical trials supporting the two drugs' approvals and was used to select patients for the trials. Both of the new agents are manufactured by GlaxoSmithKline. The BRAF mutation test is sold by bioMerieux.