USFDA accepts application for Merck KEYTRUDA plus Chemotherapy as first line treatment for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
KEYTRUDA is an anti-programmed death receptor-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells.;
Rahway: Merck, known as MSD outside of the United States and Canada, has 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.
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