FDA granted priority review to Novartis for combo therapy for melanoma

ZURICH: The U.S. Food and Drug Administration has granted priority review for Novartis’s Tafinlar in combination with Mekinist for treating some patients with advanced melanoma, the Swiss drugmaker said.

The review covers the combination therapy for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations following complete resection.

In October, the FDA also granted breakthrough therapy designation to Tafinlar in combination with Mekinist for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection, the company said in a statement.