FDA Approves Merck's Keytruda, Agilent Dako CDx for Gastric Cancer Indications

NEW YORK (GenomeWeb) – Merck announced this evening that it has received approval from the US Food and Drug Administration for its anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1.

In conjunction with that approval, Agilent Technologies also announced that its Dako PD-L1 IHC 22C3 pharmDx assay has received expanded approval to act as a companion diagnostic for Keytruda in this new indication.

Gastric and GEJ cancer patients eligible for treatment with Keytruda must be determined to have 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, Merck said. 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 confirmatory trials.

Agilent’s Dako PD-L1 IHC 22C3 pharmDx assay was first approved by the FDA in October 2015, in conjunction with Keytruda, for determining PD-L1 expression levels in patients with non-small cell lung cancer. It was granted expanded approval in October 2016 alongside Keytruda to determine

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