Posted by Michael Wonder on 11 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma
11 February 2019 - Filing includes use of Keytruda in the first-line setting as monotherapy or in combination with chemotherapy.
Merck today announced that the U.S. FDA has accepted a new supplemental biologics license application for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.
This application is based in part on data from the pivotal Phase 3 KEYNOTE-048 trial where Keytruda demonstrated a significant improvement in overall survival compared with the standard of care, as monotherapy in patients whose tumours expressed PD-L1 with CPS≥20 and CPS≥1 and in combination with chemotherapy in the total patient population. These data were presented at the European Society for Medical Oncology 2018 Congress. The FDA has granted priority review to this sBLA and set a Prescription Drug User Fee Act, or target action, date of 10 June 2019.
