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The FDA has accepted for review a supplemental Biologics License Application for pembrolizumab, an anti-PD-1 therapy, seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have already received two or more lines of chemotherapy.

FDA; gastric adenoca... - Click to enlarge in new windowFDA; gastric adenocarcinoma. FDA; gastric adenocarcinoma

The application submitted to the FDA is seeking approval for pembrolizumab monotherapy in previously treated patients at a fixed dose of 200 mg administered intravenously every 3 weeks. The application is based on data from cohort one of the phase II KEYNOTE-059 trial investigating pembrolizumab in heavily-pretreated patients with recurrent or advanced gastric or GEJ adenocarcinoma that has progressed after two or more lines of chemotherapy. Data from cohort one of KEYNOTE-059 was presented at the 2017 ASCO Annual Meeting in Chicago, June 2-6 (Abstract 4003).


Pembrolizumab is being evaluated in multiple clinical trials in more than 30 tumor types, including multiple gastrointestinal cancers. Specific to gastric cancer, pembrolizumab is being investigated as a monotherapy and in combination with other cancer treatments across multiple lines of therapy. To date, this includes four gastric cancer registration-enabling studies, and numerous other gastrointestinal cancer studies are underway.?