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. |
|
Device | PD-L1 IHC 28-8 pharmDx |
Generic Name | immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant |
Agilent Technologies, Inc. |
5301 stevens creek blvd |
santa clara, CA 95051 |
|
PMA Number | P150025 |
Supplement Number | S013 |
Date Received | 12/16/2019 |
Decision Date | 05/15/2020 |
Product Code |
PLS
|
Docket Number | 20M-1410 |
Notice Date | 05/20/2020 |
Advisory Committee |
Pathology |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
|
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. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
|
|
|