FDA Accepts Merck's sBLA for Keytruda-Based Combination as First-Line Treatment for Gastric Cancer

Intelligent Finance APP learned that the U.S. Food and Drug Administration (FDA) has accepted for review Merck & Co., Inc.'s (MRK.US) application for approval of Keytruda combination therapy as an initial treatment for gastric cancer. The company has submitted a supplemental Biologics License Application (sBLA), seeking approval for Keytruda (pembrolizumab) in combination with fluorouracil- and platinum-containing chemotherapy as a first-line treatment for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The FDA is expected to make a decision on this application by December 16.

The sBLA is supported by data from the Phase 3 trial named KEYNOTE-859. Keytruda is currently approved in the United States, in combination with Roche's Herceptin (trastuzumab), fluoropyrimidine-containing, and platinum-based chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma.

MSD noted that the use is under accelerated approval based on data from a Phase 3 clinical trial named KEYNOTE-811, and the continuation of approval may depend on the clinical benefits demonstrated in confirmatory trials.