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The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application for pembrolizumab (Keytruda®) 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 application is supported by data from the randomized, double-blind, phase 3 KEYNOTE-859 trial (ClinicalTrials.gov Identifier: NCT03675737), which included 1579 adults with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Patients were randomly assigned to receive either pembrolizumab or placebo, in addition to chemotherapy (investigator’s choice of 5-fluorouracil plus cisplatin or oxaliplatin plus capecitabine).
Findings showed the pembrolizumab plus chemotherapy demonstrated a statistically significant improvement in overall survival (primary endpoint) compared with chemotherapy alone, regardless of PD-L1 expression.
“The 5-year survival rate for patients diagnosed with metastatic gastric cancer is estimated to be only 6%, and 80% of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma have HER2-negative disease,” said Dr Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We are committed to working closely with the FDA to bring Keytruda to more patients with gastric and gastroesophageal junction cancer who are in need of additional treatment options that may help them live longer.”
A Prescription Drug User Fee Act (PDUFA) target date of December 16, 2023 has been set for the application.
Keytruda® is currently approved in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
References:
FDA accepts application for Merck’s Keytruda® (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. News release. Merck. Accessed April 13, 2023. https://www.businesswire.com/news/home/20230413005219/en/FDA-Accepts-Application-for-Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-Plus-Chemotherapy-as-First-Line-Treatment-for-Locally-Advanced-Unresectable-or-Metastatic-Gastric-or-Gastroesophageal-Junction-Adenocarcinoma.
