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Gastrointestinal Stromal Tumors (GIST)

Solid tumorIndication · GIST

GISTs are mesenchymal tumors commonly driven by KIT or PDGFRA mutations. Molecular testing is essential to identify actionable variants for targeted therapies.

Approvals
1
Therapies
6
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 Gastrointestinal Stromal Tumors (GIST) in FDA labeling.

BiomarkerBiomarker criteriaTherapies
PDGFRA
  • D842V mutation
AYVAKIT
Tumor-agnostic biomarkers

Defined at the solid tumor level and applicable to Gastrointestinal Stromal Tumors (GIST) 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 Gastrointestinal Stromal Tumors (GIST). Select a therapy to view the specific approval and eligible tests.

Therapy
AYVAKIT
avapritinib · Blueprint Medicines

PDGFRA (D842V mutation)

1 approvalView testing pathway →
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

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

3 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 Gastrointestinal Stromal Tumors (GIST). You can also explore how it appears alongside other cancers in Know Your Companions™ by searching or filtering on the main map.