FDA Accepts Novartis’ sNDA for Stage III Melanoma Treatment

The company was also granted Priority Review designation

The US Food and Drug Administration has accepted Novartis’ supplemental New Drug Application (sNDA) for filing, and granted Priority Review designation for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, following complete resection.    In October, the FDA also granted Breakthrough Therapy designation to Tafinlar in combination with Mekin...

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