FDA Accepts Application for Adjuvant Pembrolizumab for Stage III Melanoma

June 25, 2018 – The FDA has accepted a supplemental biologics license application (sBLA) for the use of pembrolizumab as an adjuvant treatment for patients with resected, high-risk stage III melanoma, according to Merck (MSD), the manufacturer of the PD-1 inhibitor. The sBLA is supported by results from the phase III EORTC 1325-MG/KEYNOTE-054 trial presented at the 2018 AACR Annual Meeting and published in the New England Journal of Medicine. In the study … (leggi tutto)