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PMA P150025S013

Device
PD-L1 IHC 28-8 pharmDx
Applicant
Agilent Technologies, Inc.
PMA number
P150025
Supplement
S013
Product code
PLS
Decision date
2020-05-15
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order 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.

Current openFDA PMA Record#

Device
PD-L1 IHC 28-8 pharmDx
Applicant
Agilent Technologies, Inc.
PMA number
P150025
Supplement
S013
Product code
PLS
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date
2020-05-15
Decision code
APPR
Date received
2019-12-16
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.