Home·Know Your Companions™·Triple-Negative Breast Cancer (TNBC)

Triple-Negative Breast Cancer (TNBC)

Solid tumorIndication · Breast

TNBC lacks ER, PR, and HER2 expression and often exhibits aggressive behavior. Genomic markers may identify patients eligible for targeted or immune therapies.

Approvals
1
Therapies
5
Biomarkers
8
Mapped tests
6

Biomarkers used in this indication

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

Indication-specific biomarkers

Defined explicitly for Triple-Negative Breast Cancer (TNBC) in FDA labeling.

BiomarkerBiomarker criteriaTherapies
PD-L1
  • protein expression
KEYTRUDA
Tumor-agnostic biomarkers

Defined at the solid tumor level and applicable to Triple-Negative Breast Cancer (TNBC) and other solid tumor cancers.

BiomarkerBiomarker criteriaTherapies
deficient mismatch repair (dMMR) proteins
  • MLH1, PMS2, MSH2 and MSH6
JEMPERLIKEYTRUDA
MSI-High
  • Microsatellite instability-High
KEYTRUDAJEMPERLI
NTRK1, NTRK2 and NTRK3
  • fusions
VITRAKVIROZLYTREK
RET
  • fusions
RETEVMO
TMB
  • TMB ≥ 10 mutations per megabase
KEYTRUDA

Therapies with biomarker-defined approvals

Each therapy below has at least one FDA companion diagnostic approval tied to Triple-Negative Breast Cancer (TNBC). Select a therapy to view the specific approval and eligible tests.

Therapy
JEMPERLI
dostarlimag-gxly · GSK

deficient mismatch repair (dMMR) proteins (MLH1, PMS2, MSH2 and MSH6); MSI-High (Microsatellite instability-High)

2 approvalsView testing pathway →
Therapy
KEYTRUDA
pembrolizumab · Merck

PD-L1 (protein expression); deficient mismatch repair (dMMR) proteins (MLH1, PMS2, MSH2 and MSH6); MSI-High (Microsatellite instability-High); TMB (TMB ≥ 10 mutations per megabase)

4 approvalsView testing pathway →
Therapy
RETEVMO
selpercatinib · Eli Lilly

RET (fusions)

1 approvalView testing pathway →
Therapy
ROZLYTREK
entrectinib · Genentech

NTRK1, NTRK2 and NTRK3 (fusions)

1 approvalView testing pathway →
Therapy
VITRAKVI
larotrectinib · Bayer

NTRK1, NTRK2 and NTRK3 (fusions)

1 approvalView testing pathway →
This indication view is scoped to Triple-Negative Breast Cancer (TNBC). You can also explore how it appears alongside other cancers in Know Your Companions™ by searching or filtering on the main map.