FDA delays GSK trametinib NDA by 3 months
This article was originally published in Scrip
Executive Summary
GlaxoSmithKline on 1 May disclosed that the US FDA has delayed by three months the Prescription Drug User Fee Act action date for the company's MEK inhibitor trametinib as a treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an US-approved test.