BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    PMA: P150025 · Supplement: S014 · Decision Oct 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
    Trade Name
    PD-L1 IHC 28-8 pharmDx
    PMA Number
    P150025
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    PLS
    Generic Name
    Immunohistochemistry assay, antibody, programmed death-ligand 1
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 18, 2021
    Date Received
    July 12, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1