FDA Approves Merck & Co.’s KEYTRUDA (Pembrolizumab) For Previously Treated Patients With Recurrent Locally Advanced Or Metastatic Gastric Or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1 (CPS Greater Than Or Equal To 1)

First Anti-PD-1 Therapy Approved in the U.S. for These 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

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) =1] as determined by an FDA-approved test, 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 is approved under the 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 the confirmatory trials.

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