Merck’s Keytruda application in adenocarcinoma accepted by FDA

Merck announced the FDA has accepted for review a new supplemental Biologics License Application 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 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 versus chemotherapy alone, regardless of PD-L1 expression, in patients who were human epidermal growth factor receptor 2 negative. The FDA has set a Prescription Drug User Fee Act target action, date of December 16, 2023. Keytruda is currently approved in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in the U.S. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.