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.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
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.
Copyright (c) 2017 CercleFinance.com. All rights reserved.