25 June 2018 - Application based on recurrence-free survival data from pivotal Phase 3 EORTC1325/KEYNOTE-054 trial.

Merck today announced that the U.S. FDA has accepted for standard review a new supplemental biologics license application for Keytruda, Merck’s anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act, or target action, date of 16 February 2019. 

This application is based on a significant benefit in recurrence-free survival demonstrated by Keytruda in the pivotal Phase 3 EORTC1325/ KEYNOTE-054 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer. These data were presented for the first time at the American Association for Cancer Research Annual Meeting 2018 and published in The New England Journal of Medicine.

Read Merck press release