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KEYTRUDA (pembrolizumab)

TherapyMerck

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

Approvals
10
Indications
7
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
Non-Small Cell Lung Cancer (NSCLC)
Solid Tumor · Lung
PD-L1
  • protein expression
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 →
Triple-Negative Breast Cancer (TNBC)
Solid Tumor · Breast
PD-L1
  • protein expression
View testing pathway →
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Solid Tumor · Stomach/GEJ
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
Solid Tumors
MSI-High
  • Microsatellite instability-High
Solid Tumors
deficient mismatch repair (dMMR) proteins
  • MLH1, PMS2, MSH2 and MSH6

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
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
PD-L1 IHC 22C3 pharmDx
Dako North America, Inc. (Agilent Technologies, Inc.)
Method
IHC
Specimen
Tissue (FFPE)
6 approvalsView 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.