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 on Friday.
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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.
(Reporting by Michael Shields; Editing by Vyas Mohan)