The FDA has accepted and granted priority review for a new supplemental Biologics License Application for pembrolizumab in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction. 

The decision is based on data from the Phase 3 KEYNOTE-590 trial in which pembrolizumab plus chemotherapy demonstrated significant improvements in the primary endpoints of overall survival and progression-free survival versus chemotherapy regardless of PD-L1 expression status and tumor histology, according to a press release.

“Patients with newly diagnosed esophageal and GEJ cancer face an aggressive disease with a poor prognosis, despite the currently available treatment options,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “We look forward to working with the FDA to bring a new option to patients in the first-line setting.” 

Data were presented at the European Society for Medical Oncology Virtual Congress 2020. The Prescription Drug User Fee Act date is April 13, 2021. 

Pembrolizumab is currently approved in the US, China and Japan as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1. 

The treatment is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.