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Novartis AG announced on Friday that the US Food and Drug Administration (FDA) has provided a regular approval for its new drug combination for treatment of metastatic melanoma. The FDA approved Tafinlar and Mekinist for treatment of metastatic melanoma based on two years overall survival in patients, the company said.
The combination was initially approved based on mid-stage data through the FDA's accelerated approval program, but the approval was contingent on data from late-stage trial. Tafinlar and Mekinist are among cancer drugs Novartis had purchased from GlaxoSmithKline Plc last year.
The combination of Tafinlar (dabrafenib) and Mekinist (trametinib) is intended for patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma, diagnosed with the help of a FDA-approved test. The drug combination is the first targeted therapy combination to show more than two years of survival in patients with metastatic melanoma.
"This approval of the combination in the US allows us to communicate more broadly with the melanoma community about the role of targeted therapies, our data, the possibility to improve clinical outcomes for patients, and our commitment to develop these medicines to their fullest potential," said Bruno Strigini, President of Novartis Oncology.
The initial approval was based on the Phase II data, which was reviewed under a priority review designation. During the clinical trials, more than 5,000 patients with BRAF mutation-positive metastatic melanoma received Tafinlar + Mekinist combination treatment. It is estimated that 200,000 new cases of metastatic melanoma are diagnosed each year around the world.