Two drugs that are targeted specifically for two genetic mutations found in the melanoma form of skin cancer have been approved by the U.S. Food and Drug Administration (FDA). The drugs are approved to treat the advanced, metastatic, and unresectable (unable to be removed by surgery) forms of melanoma. According to the National Cancer Institute, 76,690 Americans will be diagnosed with melanoma and 9,480 will die from the disease in 2013.

The two drugs target well-known mutations that are known to be present in melanoma, and a companion diagnostic test called "THxID BRAF" has been approved as well to test for the specific mutations. Tafinlar (dabrafenib) inhibits a protein called BRAF in patients who have a mutation called BRAF V600E, where the 600th amino acid in the protein is mutated from a valine to a glutamic acid. The second drug called Mekinist (trametinib) inhibits another protein called MEK and is indicated in patients who have a BRAF V600E or V600K, where the valine amino acid is substituted for a lysine because of a genetic mutation.

"Advancements in our understanding of the biological pathways of a disease have allowed for the development of Tafinlar and Mekinist, the third and fourth drugs the FDA has approved for treating metastatic melanoma in the past two years," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. Zelboraf (vemurafenib) made by Bristol-Myers Squibb and Yervoy (ipilimumab) made by Genentech/Roche were approved by the FDA in 2011 for metastatic melanoma.

Approval of the drugs and companion diagnostic test were supported by positive clinical trials that saw a delay in tumor growth by 2.4 to 3.3 months on average in patients with advanced or inoperable melanoma compared to patients on the chemotherapy agent dacarbazine. Women who are pregnant are advised not to begin treatment with the drugs because they may cause harm to the fetus.

"The co-approval of Tafinlar and Mekinist and the second companion diagnostic for BRAF mutation detection demonstrates the commitment of pharmaceutical and diagnostic partners to develop products that detect and target the molecular drivers of cancer," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Devices and Radiological Health in the FDA's Center for Devices and Radiological Health.

With skin cancer on the rise across the world, new treatments are needed to provide patients with courses of action in late stages of the disease. Melanoma is the easiest type of cancer to prevent and is usually caused by excessive sun exposure. The usage of sunblock and protective clothing can prevent the development of the cancer. Melanoma has one of the highest cure rates of any cancer, at 95 percent at the first stage, because simple dermatology visits can spot signs of the cancer on the skin and remove lesions before they progress and spread throughout the body. Once the cancer has spread, it is extremely difficult to cure the person of metastasized melanoma, with survivals hovering around 15 percent.