FDA adds fresh ‘breakthrough’ for Novartis' cancer combo Tafinlar and Mekinist
Just four months after adding an FDA OK to sell its combo of Tafinlar and Mekinist for non-small cell lung cancer with a BRAF V600E mutation, Novartis says that US regulators have handed them another breakthrough therapy designation on stage III melanoma.
The BRAF/MEK combination — bagged in their big asset swap with GlaxoSmithKline — should now get VIP treatment for stage III melanoma cases involving this particular mutation after investigators posted a 53% reduction in the risk of death or recurrence in Phase III compared to placebo last month.
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