FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma

July 5, 2018 – The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or target action, date is February 16, 2019. This sBLA is based on a significant benefit in recurrence-free survival demonstrated by pembrolizumab in the phase III … (leggi tutto)