FDA Accepts Application for Merck’s KEYTRUDA Plus Chemo as First-Line in Gastric Cancer

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The sBLA is based on data from the KEYNOTE-859 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) versus chemotherapy alone, regardless of PD-L1 expression, in patients who were human epidermal growth factor receptor 2 (HER2) negative. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of December 16, 2023.

https://finance.yahoo.com/news/fda-accepts-application-merck-keytruda-104500938.html