Keytruda (pembrolizumab) is filed at FDA to treat advanced gastric or gastroesophageal junction adenocarcinoma.- Merck Inc.

Merck announced that the FDA has accepted for review a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have already received two or more lines of chemotherapy. The FDA granted Priority Review with a PDUFA, or target action, date of Sept. 22, 2017. The application submitted to the FDA is seeking approval for Keytruda monotherapy in previously treated patients at a fixed dose of 200 mg administered intravenously every three weeks.

The application is based on data from cohort one of the phase II KEYNOTE-059 trial investigating Keytruda in heavily pretreated patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma that has progressed after two or more lines of chemotherapy. Data from cohort one of KEYNOTE-059 will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 2 – 6, 2017 during an oral session on Sunday, June 4 .