BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    PMA: P150025 · Supplement: S013 · Decision May 15, 2020
    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
    S013
    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
    May 15, 2020
    Date Received
    December 16, 2019
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    20M-1410

    Advisory Committee Statement

    Approval application (PMA) supplement submitted to expand the indication for the PD-L1 IHC 28-8 pharmDx to include detection of PD-L1 protein in NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). The device, as modified, will be marketed under the trade name PD-L1 IHC 28-8 pharmDx and is indicated for in vitro diagnostic use.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 Indication Tumor Indication PD-L1 Expression Clinical Cut Off Intended UseNSCLC >=1% tumor cell expression PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).PD-L1 expression (>=1% or ?5% or >=10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC 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 from OPDIVO®. See the OPDIVO® and YERYOV® 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