Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC
Agilent Technologies, Inc. (A)
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Source: Business Wire
PD-L1 IHC 22C3 pharmDx Can Now Be Used to Identify a Broader Range of NSCLC Patients for First-line Treatment With KEYTRUDA® (pembrolizumab) SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has updated its approval of the company’s PD-L1 IHC 22C3 pharmDx assay. The assay can now be used as a companion diagnostic to identify a broader range of patients with stage III or metastatic non-small cell lung cancer (NSCLC) for first-line treatment with KEYTRUDA, a targeted anti-PD-1 therapy manufactured by Merck & Co. (known as MSD outside the United States and Canada). The FDA previously approved the assay to identify metastatic NSCLC patients whose tumors express PD-L1 Tumor Proportion Score (TPS) = 50% for first-line treatment with KEYTRUDA. Now, patients with stage III NSCLC who are not candidates fo
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