A melanoma drug developed by GlaxoSmithKline now has the approval to be used in treating skin cancer patients in Europe.
The British drugmaker, which operates its U.S. headquarters in Research Triangle Park, said the European Commission has granted marketing authorization for Tafinlar, a drug developed to treat patients with the most advanced form of melanoma that cannot be removed by surgery.
GSK received U.S. approval for Tafinlar in May. At that time, the Food and Drug Administration also approved another GSK melanoma drug, trametinib, which is now called Mekinist. Tafinlar and Mekinist approvals were for use of the drugs separately and not in combination. But GSK has since filed for FDA approval for use of the two drugs together to take a multi-pronged approach to fighting melanoma.
Tafinlar takes a personalized medicine approach to treating cancer. The drug works only on patients with a particular genetic mutation. Before doctors treat a patient with the drug, they must first use a companion diagnostic to confirm that the patient has the BRAF V600 mutation.
“With this new personalized medicine, we hope to make a meaningful difference in the lives of appropriate patients with metastatic melanoma; a devastating disease and a cancer with one of the lowest survival rates,” Dr. Paolo Paoletti, president, GlaxoSmithKline Oncology, said in a statement.
