SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Keytruda (pembrolizumab), the drug’s manufacturer Merck announced recently. The drug is now approved as a third-line treatment for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors test positive for a certain protein identified by an FDA-approved test.
The new indication was approved under the FDA program of accelerated approval based on tumor response rate and durability, with continued approval contingent on verification and description of benefit in future confirmatory trials, Merck said. Keytruda is an anti-programmed death receptor-1, or PD-1 therapy, which helps the immune system detect and fight tumor cells.
“Keytruda is now the first PD-1 checkpoint inhibitor approved in the United States for previously treated advanced gastric or GEJ cancer, helping to address a recognized treatment gap,” Merck Research Laboratories president Dr. Roger Perlmutter said. “This approval marks another milestone — the 10th new indication for Keytruda in just three years — which further demonstrates both our commitment to patients and the progress we have made in the fight against many cancers.”