FDA Advisory Committee defers decision on Keytruda to treat early-stage neoadjuvant triple-negative breast cancer.- Merck Inc.

An FDA advisory committee voted unanimously to recommend deferral of a regulatory decision on pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer. The FDA’s Oncologic Drugs Advisory Committee (ODAC) did not support accelerated approval of Keytruda (pembrolizumab , an anti-PD-1 monoclonal antibody, in combination with chemotherapy in the neoadjuvant setting and as a single agent in the adjuvant setting for this patient population, due in part to concerns about immature EFS and OS data from the KEYNOTE-522 trial. On 30 July 2020, Merck Inc., had announced that the FDA has accepted two new supplemental Biologics License Applications (sBLAs) for Keytruda, Merck’s anti-PD-1 therapy. The FDA has accepted and granted priority review for a new sBLA 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 tumors express PD-L1 (Combined Positive Score [CPS] greater than 10), based on the Phase III KEYNOTE-355 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of 28 November, 2020. ( now FDA approved). The FDA also accepted for standard review a new sBLA for Keytruda for the treatment of patients with high-risk early-stage TNBC, in combination with chemotherapy as neoadjuvant treatment, and then as a single agent as adjuvant treatment after surgery, based on the Phase III KEYNOTE-522 trial. The PDUFA date for this application is 29 March 2021.