The U.S. Food and Drug Administration granted priority review designation to Novartis AG's Tafinlar in combination with Mekinist for a certain type of skin cancer.
The designation is based on results from the phase 3 COMBI-AD study,which evaluated the combination as an adjuvant treatment in patients with stage 3 melanoma whose tumors express mutations BRAF V600E or BRAF V600K, after complete surgical resection. The study met its primary goal by reducing the risk of disease recurrence or death by 53% compared to placebo.
Priority review ensures that the FDA takes action upon an application within six months of submission, instead of the standard 10 months.
Tafinlar in combination with Mekinist is already approved for unresectable or metastatic BRAF V600 mutation-positive melanoma, as well as metastatic BRAF V600 mutation-positive non-small cell lung cancer. It received breakthrough therapy designation from the FDA in October.