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FDA expands use of Agilent CDx for gastric cancer , 11/17

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November 2017—Agilent Technologies announced its Dako PD-L1 IHC 22C3 pharmDx assay has an expanded label approved by the FDA for use as an aid in identifying gastric or gastroesophageal junction adenocarcinoma patients for treatment with Keytruda (pembrolizumab), an anti-PD-1 therapy manufactured by Merck. The FDA also announced that Keytruda is approved for the treatment of patients with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma. These tumors express PD-L1 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.

Agilent Technologies, 408-345-8886

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