Novartis: melanoma drug wins FDA breakthrough status.

(CercleFinance.com) - Novartis said on Monday that it has won "breakthrough therapy" designation from the US Food and Drug Administration for a combination therapy targeting melanoma.


The Swiss drugmaker said the combination of Tafinlar and Mekinist received FDA breakthrough therapy designation for stage III BRAF V600 mutation-positive melanoma patients.

Novartis said the designation is based on results from a Phase III study of 870 patients with stage III melanoma, which showed that the combination therapy significantly reduced the risk of disease recurrence or death by 53% compared to placebo.


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