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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePD-L1 IHC 28-8 pharmDx
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Blvd
Santa Clara, CA 95051
PMA NumberP150025
Supplement NumberS014
Date Received07/12/2021
Decision Date10/18/2021
Product Code PLS 
Advisory Committee Pathology
Clinical TrialsNCT02632409
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to update the current approved urothelial carcinoma (UC) indication of PD-L1 IHC 28-8 pharmDx: to include enhanced disease-free survival and new clinical data from Bristol-Myers Squibb (BMS) clinical study CA209274 (CHECKMATE-274) in this existing indication.PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial carcinoma (UC) tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity.Companion Diagnostic IndicationTumor Indication PD-L1 ExpressionClinical Cutoff Intended UseNSCLC >= 1% tumor cell expression PD-L1 ICH 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO (nivolumab) in combination with YERVOY (ipilimumab).When used in accordance with approved therapeutic labeling:PD-L1 expression (>= 1% or >= 5% or >= 10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC (nsNSCLC) may be associated with enhanced survival from OPDIVO.PD-L1 expression (>= 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO.PD-L1 expression (>= 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate and enhanced disease-free survival from OPDIVO®.See the OPDIVO® and YERVOY® product labels for specific clinical circumstances guiding PD-L1 testing.
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