The U.S. Food and Drug Administration has granted priority review for a new supplemental biologics license application for pembrolizumab (Keytruda; Merck) 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 (GEJ), according to a press release.
The application was based on data from the Phase 3 KEYNOTE-590 trial which found pembrolizumab plus chemotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients regardless of PD-L1 expression status and tumor histology.
“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, in a press release. "We look forward to working with the FDA to bring a new option to patients in the first-line setting.”
Read the full press release here.