Posted by Michael Wonder on 04 Sep 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the treatment of Merkel cell carcinoma, a rare form of skin cancer
4 September 2018 - Application based on data from Phase 2 KEYNOTE-017 trial.
Merck today announced that the U.S. FDA has accepted and granted priority review for a new supplemental biologics license application seeking accelerated approval for Keytruda, Merck’s anti-PD-1 therapy, for the treatment of adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. This application is based on data from the Phase 2 KEYNOTE-017 trial including overall response rate and duration of response; these data were presented earlier this year at the 2018 American Society of Clinical Oncology Annual Meeting. In July 2017, Keytruda was granted breakthrough therapy designation by the FDA for this indication.
The FDA has set a Prescription Drug User Fee Act, or target action, date of 28 December 2018.
