FDA Grants Priority Review to sBLA for Pembrolizumab in Recurrent or Advanced Gastric or GEJ Adenocarcinoma

The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) 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. The FDA granted Priority Review with a Prescription Drug User Fee Act (PDUFA), or target action, date of September 22, 2017.

“An estimated [100,000] people are living with gastric cancer in the United States, yet little progress has been made in bringing forward new treatment options to these patients for whom chemotherapy has long been the standard of care,” said Roger Dansey, MBBCh, FCP(SA), Senior Vice President and Therapeutic Area Head, Oncology Late-Stage Development, Merck Research Laboratories. “We look forward to working with the FDA to bring [pembrolizumab] to people with gastric cancer who have [had disease progression] after receiving chemotherapy and are in urgent need of another option.”

KEYNOTE-059 Trial

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 will be presented by Fuchs et al at the 2017 ASCO Annual Meeting (Abstract 4003). 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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