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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 22C3 pharmDx
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Blvd
Santa Clara, CA 95051
PMA NumberP150013
Supplement NumberS016
Date Received02/25/2019
Decision Date07/30/2019
Product Code PLS 
Docket Number 19M-3309
Notice Date 08/21/2019
Advisory Committee Pathology
Clinical TrialsNCT02564263
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the PD-L1 IHC 22C3 pharmDx. PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using monoclonal mouse anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC), cervical cancer, urothelial carcinoma and head and neck squamous cell carcinoma (HNSCC) tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. PD-L1 protein expression in gastric or GEJ adenocarcinoma, ESCC, cervical cancer, urothelial carcinoma and HNSCC is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.Companion Diagnostic IndicationsTumor Indication PD-L1 Expression Level Intended UseNSCLC TPS greater than or equal to 1% PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). **Gastric or GEJ Adenocarcinoma CPS greater than or equal to 1 PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA® (pembrolizumab).ESCC CPS greater than or equal to 10 PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying esophageal squamous cell cancer patients for treatment with KEYTRUDA® (pembrolizumab). Cervical Cancer CPS greater than or equal to 1 PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying cervical cancer patients for treatment with KEYTRUDA® (pembrolizumab).Urothelial Carcinoma CPS greater than or equal to 10 PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying urothelial carcinoma patients for treatment with KEYTRUDA® (pembrolizumab). **HNSCC CPS 1 PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying HNSCC patients for treatment with KEYTRUDA® (pembrolizumab). ****See the KEYTRUDA® product label for specific clinical circumstances guiding PD-L1 testing.For in vitro diagnostic use.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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