Posted by Michael Wonder on 06 Aug 2021
Merck’s Keytruda (pembrolizumab) significantly prolonged recurrence-free survival compared to placebo as adjuvant therapy for patients with stage II resected high-risk melanoma in Phase 3 KEYNOTE-716 trial
5 August 2021 - US FDA grants priority review to Merck’s application for Keytruda based on these data.
Merck today announced that the Phase 3 KEYNOTE-716 trial investigating Keytruda, Merck’s anti-PD-1 therapy, met its primary endpoint of recurrence-free survival for the adjuvant treatment of patients with surgically resected high-risk stage II melanoma.
Based on these data, the U.S. FDA has accepted a new supplemental biologics license application for Keytruda for the adjuvant treatment of adult and paediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.
The FDA granted the application priority review and assigned a Prescription Drug User Fee Act, or target action, date of 4 December 2021.
