Muscle Invasive Bladder Cancer (MIBC)
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 Muscle Invasive Bladder Cancer (MIBC) in FDA labeling.
| Biomarker | Biomarker criteria | Therapies |
|---|---|---|
| Circulating tumor DNA (ctDNA) molecular residual disease (MRD) |
|
Defined at the solid tumor level and applicable to Muscle Invasive Bladder Cancer (MIBC) and other solid tumor cancers.
Therapies with biomarker-defined approvals
Each therapy below has at least one FDA companion diagnostic approval tied to Muscle Invasive Bladder Cancer (MIBC). 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)
Circulating tumor DNA (ctDNA) molecular residual disease (MRD) (ctDNA MRD)
NTRK1, NTRK2 and NTRK3 (fusions)