Merck & Co.’s Keytruda Gets FDA Approval for Gastric Cancer

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This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.

Merck & Co. has received approval from FDA for a gastric cancer indication for its anti-cancer biologic, Keytruda (pembrolizumab), the company said on Sep. 22, 2017. Keytruda is a blockbuster drug for Merck with 2016 sales of $1.4 billion.

FDA approved Keytruda, an anti-programmed death receptor-1 (PD-1) therapy, for specifically treating recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. The therapy is intended for patients with disease progression on or after two or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.   

This indication was approved under FDA’s accelerated approval regulations based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

“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,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories, in a company press release. “This approval marks another milestone-the tenth 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.”


In addition to the new gastric cancer indication, Keytruda is now approved by FDA for treating melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, and microsatellite instability-high (MSI-H) cancer.

Source: Merck & Co.