PD-L1

BiomarkerProtein Expression

PD-L1 expression is used to guide immune checkpoint inhibitor therapy. Expression thresholds vary by tumor type and therapy.

Approvals

Indications

Therapies

Mapped tests

Where this biomarker is used

Each approval combines this biomarker with a specific indication and therapy. Select a therapy in the tables below to open its FDA-defined testing pathway.

Indication-specific approvals

Approvals where PD-L1 is defined directly in the indication labeling.

Indication	Biomarker criteria	Therapies
Cervical Cancer Solid Tumor · Cervix	protein expression	KEYTRUDA
Esophageal Squamous Cell Carcinoma (ESCC) Solid Tumor · Esophagus	protein expression	KEYTRUDA
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Solid Tumor · Stomach/GEJ	protein expression	KEYTRUDA
Head and Neck Squamous Cell Carcinoma (HNSCC) Solid Tumor · Head & Neck	protein expression	KEYTRUDA
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung	protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%]) protein expression protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]) protein expression (tumor cell staining ≥1%) protein expression [Tumor Proportion Score (TPS) ≥ 50%]	LIBTAYO TECENTRIQ OPDIVO + YERVOY KEYTRUDA
Triple-Negative Breast Cancer (TNBC) Solid Tumor · Breast	protein expression	KEYTRUDA
Urothelial Cancer Solid Tumor · Bladder	protein expression (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area)	TECENTRIQ

Tumor-agnostic approvals

Approvals defined at the solid tumor level where PD-L1 is part of the eligibility criteria.

No tumor-agnostic approvals are currently mapped for this biomarker.

Tests that measure this biomarker

These assays report PD-L1 as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test

PD-L1 IHC 22C3 pharmDx

Dako North America, Inc.

Method

IHC

Specimen

Tissue (FFPE)

Reports PD-L1 as part of its biomarker panel.

7 approvalsView test profile →

Test

PD-L1 IHC 28-8 pharmDx

Dako North America, Inc.

Method

IHC

Specimen

Tissue (FFPE)

Reports PD-L1 as part of its biomarker panel.

1 approvalView test profile →

Test

Ventana PD-L1 (SP142) Assay

Ventana Medical Systems, Inc.

Method

IHC

Specimen

Tissue (FFPE)

Reports PD-L1 as part of its biomarker panel.

2 approvalsView test profile →

Test

Ventana PD-L1 (SP263) Assay

Ventana Medical Systems, Inc.

Method

IHC

Specimen

Tissue (FFPE)

Reports PD-L1 as part of its biomarker panel.

2 approvalsView test profile →

This view is scoped to PD-L1. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.