FDA accepted sBLA for Merck’s Keytruda to treat Gastroesophageal Junction Adenocarcinoma

CAR-T Digest - August 2020

Weekly Digest - 08-14 Apr 2023

13 Apr 2023: Keytruda (Pembrolizumab) / Gastric or Gastroesophageal Junction Adenocarcinoma (GEJ) / Merck: US FDA accepted new Supplemental Biologics License Application (sBLA)

The FDA has accepted a sBLA application for Pembrolizumab (Keytruda) in combination with chemotherapy for patients with 1L GEJ
This application is supported by the data from Phase 3 KEYNOTE-859 trial in which addition of Pembrolizumab to Chemo resulted in a statistically significant improvement in overall survival (OS) regardless of PD-L1 expression in patients with HER2-negative disease
“We are committed to working closely with the FDA to bring KEYTRUDA to more patients with gastric and gastroesophageal junction cancer who are in need of additional treatment options that may help them live longer.” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories
Merck is continuing to study KEYTRUDA for multiple uses in hepatobiliary, esophageal, pancreatic, colorectal, and biliary tract cancers