Agilent CDx nets expanded FDA approval
December 2016

CARPINTERIA, Calif.—As the fourth quarter of 2016 kicked off, Agilent Technologies Inc. shared news that its Dako PD-L1 IHC 22C3 pharmDx now features an expanded label approved by the U.S. Food and Drug Administration for use in determining PD-L1 expression status to inform treating patients with metastatic non-small cell lung cancer (NSCLC) with Merck’s Keytruda (pembrolizumab). The expanded intended use enables the PD-L1 IHC 22C3 pharmDx test to detect PD-L1 expression in a broader range of patients, namely those with a PD-L1 tumor proportion score (TPS) of 1 percent or more. Keytruda has also been approved for the first-line treatment of metastatic NSCLC patients whose tumors express high levels of PD-L1 (TPS of 50 percent or more) or for previously treated metastatic NSCLC patients whose tumors express PD-L1 (TPS of 1 percent or more). Dako’s PD-L1 IHC 22C3 pharmDx was developed in partnership with Merck & Co.

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