Under its accelerated approval program, the . Food and Drug Administration (FDA) granted a new indication for Keytruda® (pembrolizumab - Merck) on Sept. 22, 2017. The human programmed death receptor-1 (PD-1)-blocking antibody now is approved to treat recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that expresses PD-L1. Eligible patients must have disease progression during or after finishing treatment with at least two other therapies -- including chemotherapy (chemo) containing fluoropyrimidine and platinum-based drugs. Additionally, their tumors will have to test positive for PD-1 with the Dako PD-L1 IHC 22C3 pharmDx companion diagnostic test. Either in combination with other drugs or alone, Keytruda has indications to treat multiple other types of cancer. In May 2017, it became the first drug to be FDA approved for treating colorectal cancer and any solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) regardless of the tumors’ primary site of origin. Full prescribing information is available here .
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