FDA accepts sBLA for Keytruda in resected, high-risk stage III melanoma.- Merck Inc.

Merck Inc. announced that the FDA has accepted for standard review a new supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act (PDUFA), or target action, date of February 16, 2019.

This sBLA is based on a significant benefit in recurrence-free survival demonstrated by Keytruda in the pivotal Phase III EORTC1325/ KEYNOTE-054 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). These data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2018 and published in The New England Journal of Medicine.