Regulators in the USA have given the green light to GlaxoSmithKline’s melanoma combination treatment Mekinist/Tafinlar.
Specifically, the US Food and Drug Administration has approved Mekinist (trametinib) for use in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable or metastatic melanoma who have BRAF V600E or V600K mutations. The approval is based on data from a Phase I/II study comparing the combo to dabrafenib monotherapy.
The Mekinist/Tafinlar combination was granted a priority review by the FDA in September and both drugs were individually approved in May, alongside a companion diagnostic made by French firm bioMerieux.
Paolo Paoletti, president of GSK Oncology, said the approval “marks another key moment in what continues to be a rapid evolution of the treatment landscape for metastatic melanoma patients”. He added that combining agents that target different mechanisms regulating the growth of cancer cells “is one of the promising areas in cancer research,” saying that the firm hopes Mekinist/Tafinlar “will become part of the new standard of care for appropriate patients”.
