The green light for the combined use of Tafinlar, also known as dabrafenib, and Mekinist, or trametinib, from the Food and Drug Administration (FDA) is the first of its kind for a form of the disease with a specific genetic profile. Both drugs are already approved for separate use but GSK believes they will have a longer-lasting effect if given together. Industry analysts also see a combination offering the greatest commercial potential. Tafinlar, which is similar to Roche’s rival medicine Zelboraf, is designed to work in patients with a mutation of a gene known as BRAF. So-called BRAF inhibitors have been remarkably effective in shrinking melanoma tumors but most patients eventually develop resistance to the drugs. By combining Tafinlar with Mekinist, which works in a different way, the hope is that the cancer will be held at bay for longer. The FDA approval, which was announced late on Wednesday, covers the treatment of melanoma that cannot be removed by surgery or which has spread to other organs. Melanoma is diagnosed in nearly 160,000 people worldwide each year. It can spread quickly to internal organs and average survival is six to nine months.
GSK melanoma drug combination wins accelerated U.S. approval.