Biliary Tract Cancer
Biliary Tract Cancer includes malignancies of the bile ducts and gallbladder. These tumors often present late and may harbor actionable genomic alterations.
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.
Defined explicitly for Biliary Tract Cancer in FDA labeling.
| Biomarker | Biomarker criteria | Therapies |
|---|---|---|
| ERBB2 (HER2) |
|
Defined at the solid tumor level and applicable to Biliary Tract Cancer and other solid tumor cancers.
Therapies with biomarker-defined approvals
Each therapy below has at least one FDA companion diagnostic approval tied to Biliary Tract Cancer. Select a therapy to view the specific approval and eligible tests.
deficient mismatch repair (dMMR) proteins (MLH1, PMS2, MSH2 and MSH6); MSI-High (Microsatellite instability-High)
deficient mismatch repair (dMMR) proteins (MLH1, PMS2, MSH2 and MSH6); MSI-High (Microsatellite instability-High); TMB (TMB ≥ 10 mutations per megabase)
RET (fusions)
NTRK1, NTRK2 and NTRK3 (fusions)
NTRK1, NTRK2 and NTRK3 (fusions)
ERBB2 (HER2) (HER-2 protein overexpression)