30 July 2020 - FDA grants priority review to supplemental biologics license application for Keytruda plus chemotherapy for the treatment of certain patients with metastatic triple negative breast cancer based on KEYNOTE-355 trial.

Merck today announced that the U.S. FDA has accepted two new supplemental biologics license applications for Keytruda, Merck’s anti-PD-1 therapy. The FDA has accepted and granted priority review for a new application seeking accelerated approval for Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10), based on the Phase 3 KEYNOTE-355 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of 28 November 2020. 

The FDA also accepted for standard review a new application for Keytruda for the treatment of patients with high-risk early-stage TNBC, in combination with chemotherapy as neo-adjuvant treatment, and then as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial. The PDUFA date for this application is 29 March 2021.

Read Merck press release