Home·Know Your Companions™·Therapies·KEYTRUDA

KEYTRUDA (pembrolizumab)

TherapyMerck

KEYTRUDA (pembrolizumab) from Merck is a PD-1–directed immunotherapy used across a broad range of biomarker-defined solid tumors.

Approvals
13
Indications
10
Biomarkers
4
Mapped tests
4

Where this therapy is approved with a companion diagnostic

Each row represents a defined combination of indication, biomarker criteria, and KEYTRUDA. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

Approvals where KEYTRUDA is tied to a specific indication and biomarker definition.

IndicationBiomarker criteriaNotes
Urothelial Cancer
Solid Tumor · Bladder
Unknown
    		View testing pathway →
    Esophageal or Gastroesophageal Junction (GEJ) Carcinoma
    Solid Tumor
    PD-L1
    • PD-L1 protein expression [Combined Positive Score (CPS) ≥ 1]
    		View testing pathway →
    Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
    Solid Tumor · Ovary/Peritoneum
    PD-L1
    • PD-L1 protein expression [Combined Positive Score (CPS) ≥ 1]
    		View testing pathway →
    Non-Small Cell Lung Cancer (NSCLC)
    Solid Tumor · Lung
    PD-L1
    • PD-L1 protein expression [Tumor Proportion Score (TPS) ≥ 1%]
    		View testing pathway →
    Cervical Cancer
    Solid Tumor · Cervix
    PD-L1
    • protein expression
    		View testing pathway →
    Head and Neck Squamous Cell Carcinoma (HNSCC)
    Solid Tumor · Head & Neck
    PD-L1
    • protein expression
    		View testing pathway →
    Esophageal Squamous Cell Carcinoma (ESCC)
    Solid Tumor · Esophagus
    PD-L1
    • protein expression
    		View testing pathway →
    Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
    Solid Tumor · Stomach/GEJ
    PD-L1
    • protein expression
    		View testing pathway →
    Triple-Negative Breast Cancer (TNBC)
    Solid Tumor · Breast
    PD-L1
    • protein expression
    		View testing pathway →
    Tumor-agnostic approvals

    Approvals defined at the solid tumor level where biomarker criteria determine eligibility for KEYTRUDA.

    LevelBiomarker criteriaNotes
    Solid Tumors
    TMB
    • TMB ≥ 10 mutations per megabase
    		View testing pathway →
    Solid Tumors
    MSI-High
    • Microsatellite instability-High
    		View testing pathway →
    Solid Tumors
    deficient mismatch repair (dMMR) proteins
    • MLH1, PMS2, MSH2 and MSH6
    		View testing pathway →

    Tests used in these approvals

    These assays are identified in FDA labeling or sponsor materials as companion diagnostics or acceptable tests when considering KEYTRUDA for eligible patients.

    Test
    PD-L1 IHC 22C3 pharmDx
    Dako North America, Inc. (Agilent Technologies, Inc.)
    Method
    IHC
    Specimen
    Tissue (FFPE)
    9 approvalsView test profile →
    Test
    FoundationOne CDx
    Foundation Medicine, Inc.
    Method
    NGS
    Specimen
    Tissue (FFPE)
    2 approvalsView test profile →
    Test
    MI Cancer Seek (MCS)
    Caris Life Sciences
    Method
    NGS
    Specimen
    Tissue (FFPE)
    1 approvalView test profile →
    Test
    Ventana MMR RxDx Panel
    Ventana Medical Systems, Inc. (Roche Diagnostics)
    Method
    IHC
    Specimen
    Tissue (FFPE)
    1 approvalView test profile →
    This view is scoped to KEYTRUDA (pembrolizumab). You can also see how it compares with other therapies and indications on the main Know Your Companions™ map.