Urothelial Cancer
Urothelial Cancer arises from the bladder and urinary tract lining, frequently showing high mutational burden. Biomarkers help guide targeted and immunotherapy options.
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 Urothelial Cancer in FDA labeling.
| Biomarker | Biomarker criteria | Therapies |
|---|---|---|
| FGFR3 |
| |
| PD-L1 |
|
Defined at the solid tumor level and applicable to Urothelial Cancer and other solid tumor cancers.
Therapies with biomarker-defined approvals
Each therapy below has at least one FDA companion diagnostic approval tied to Urothelial Cancer. Select a therapy to view the specific approval and eligible tests.
FGFR3 (Exon 7: R248C (c.742C>T), S249C (c.746C>G); exon 10: G370C (c.1108G>T) and Y373C (c.1118A>G); and fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3))
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)
PD-L1 (protein expression (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area))
NTRK1, NTRK2 and NTRK3 (fusions)