Keytruda + chemotherapy filed at FDA supplemental sBLA as first-line treatment for locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer.

Merck Inc., has announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda, Merck’s anti-PD-1 therapy, 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). This sBLA is based on data from the pivotal Phase III KEYNOTE-590 trial, in which Keytruda plus chemotherapy demonstrated significant improvements in the primary endpoints – overall survival (OS) and progression-free survival (PFS) – versus chemotherapy in these patients regardless of PD-L1 expression status and tumor histology. These data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 13, 2021.