Two GSK melanoma drugs win FDA approval

The US FDA has approved two of GlaxoSmithKline's melanoma drugs for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma. Both drugs are being approved as single agents, not as a combination treatment.

• Tafinlar (dabrafenib) is a BRAF inhibitor, that's been approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation.
• Mekinist (trametinib) is a MEK inhibitor, approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations.

"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."

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

The FDA also approved a companion diagnostic genetic test called the THxID BRAF test, which will help determine if a patient's melanoma cells have the V600E or V600K mutation in the BRAF gene. This test is manufactured by bioMérieux of Grenoble, France.

Melanoma is the most dangerous type of skin cancer and approximately 132,000 cases occur globally each year, according to the WHO. One in every three cancers diagnosed is a skin cancer, and according to Skin Cancer Foundation, one in every five Americans will develop skin cancer in their lifetime.