Cholangiocarcinoma
Cholangiocarcinoma is a cancer of the bile ducts characterized by late presentation and diverse genomic drivers. Molecular testing can identify treatment-relevant 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 Cholangiocarcinoma in FDA labeling.
Defined at the solid tumor level and applicable to Cholangiocarcinoma and other solid tumor cancers.
Therapies with biomarker-defined approvals
Each therapy below has at least one FDA companion diagnostic approval tied to Cholangiocarcinoma. 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)
FGFR2 (fusions and select rearrangements)
RET (fusions)
NTRK1, NTRK2 and NTRK3 (fusions)
IDH1 (Single nucleotide variants)
NTRK1, NTRK2 and NTRK3 (fusions)