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The PD-L1 stain paired with nivolumab: tumour-cell staining of 1% or more for nivolumab with ipilimumab in lung cancer, and a combined positive score of 1 or more in oesophageal and gastric cancers.
Agilent's (Dako's) PD-L1 IHC 28-8 pharmDx was first approved on 9 October 2015 (PMA P150025) for detecting PD-L1 in non-squamous non-small-cell lung cancer. A supplement on 15 May 2020 made it the companion diagnostic for nivolumab with ipilimumab in non-small-cell lung cancer at tumour-cell staining of 1% or more. A supplement on 1 July 2026 added nivolumab in oesophageal squamous cell carcinoma and in gastric, gastro-oesophageal junction and oesophageal adenocarcinoma at a combined positive score (CPS) of 1 or more. It uses a different antibody from the 22C3 assay that is paired with pembrolizumab.
Immunohistochemistry with the rabbit monoclonal anti-PD-L1 antibody clone 28-8; the FDA approval order defines PD-L1 expression in lung cancer as the percentage of tumour cells with membrane staining at any intensity. Connects to PD-L1.
| Region | Year | Indication |
|---|---|---|
| US | 2015 | PD-L1 detection in non-squamous NSCLC (original PMA) |
| US | 2020 | Companion diagnostic for nivolumab with ipilimumab in NSCLC (tumour-cell staining 1% or more) |
| US | 2026 | Companion diagnostic for nivolumab in oesophageal squamous cell carcinoma and gastric, GEJ and oesophageal adenocarcinoma (CPS 1 or more) |
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Query for this drug: (TITLE:"PD-L1 IHC 28-8 pharmDx" OR ABSTRACT:"PD-L1 IHC 28-8 pharmDx") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about PD-L1 IHC 28-8 pharmDx, not a curated reading list.
Shares PD-L1 TC score (tumour-cell score, SP263 and 28-8), PD-L1 expression testing (22C3, SP142, SP263), Companion diagnostics, Immunohistochemistry (IHC) and the tag test.
Shares Agilent Technologies (Dako), Companion diagnostics, Immunohistochemistry (IHC), Ipilimumab and the tag test.
Shares Agilent Technologies (Dako), Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares PD-L1 IHC 22C3 pharmDx, PD-L1 expression testing (22C3, SP142, SP263), Companion diagnostics, Immunohistochemistry (IHC) and the tag test.
Shares Agilent Technologies (Dako), Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Agilent Technologies (Dako), Companion diagnostics, Non-small-cell lung cancer and the tag test.
Shares Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry, Gastric & gastro-oesophageal junction cancer and the tag test.
Shares Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry, Non-small-cell lung cancer and the tag test.
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