Agilent PD-L1 Assay Receives FDA Approval for Use as a Companion Diagnostic
Agilent Technologies, Inc. (A)
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Source: Business Wire
Assay will help guide treatment decisions in cases of non-small cell lung cancer SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 28-8 pharmDx for expanded use in non-small cell lung cancer (NSCLC).Now, physicians will be able to use the PD-L1 IHC 28-8 pharmDx assay as an aid in identifying patients with metastatic NSCLC for treatment with the dual immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab), manufactured by Bristol Myers Squibb. Based on the results of the Phase 3 CheckMate -227 clinical trial, Opdivo in combination with Yervoy was approved as first-line treatment for patients with metastatic NSCLC whose tumors express PD-L1 (=1%) as determined by an FDA-approved test.“The expanded use of PD-L1 IHC 28-8 pharmDx will give physicians in the USA critical information to inform first-line treatment decisions for patients with metastatic no
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