FDA accepts filing of Keytruda plus chemo for gastric or gastroesophageal junction adenocarcinoma
Merck Inc announced the FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda (pembrolizumab) 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.
KEYNOTE-859 is a randomized, double-blind Phase III trial (ClinicalTrials.gov, NCT03675737) evaluating Keytruda in combination with chemotherapy compared to placebo in combination with chemotherapy for the first-line treatment of patients with HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. The primary endpoint is OS, and secondary endpoints include progression-free survival, ORR, duration of response and safety.
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