FDA Gives Keytruda Priority Review for Esophageal and Gastroesophageal Junction Cancer

The FDA has granted Merck’s blockbuster cancer drug Keytruda (pembrolizumab) a priority review to assess it as a first-line treatment for a specific form of esophageal cancer.

The agency will review phase 3 data demonstrating that Keytruda plus chemotherapy significantly improved outcomes vs. chemotherapy alone in patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction.

The FDA has set an April 13, 2021, decision date for the supplemental Biologics License Application.