Ovarian Cancer
Ovarian Cancer includes several histologic subtypes with frequent DNA repair defects. Molecular biomarkers play a key role in guiding targeted therapy decisions.
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 Ovarian Cancer in FDA labeling.
Defined at the solid tumor level and applicable to Ovarian Cancer and other solid tumor cancers.
Therapies with biomarker-defined approvals
Each therapy below has at least one FDA companion diagnostic approval tied to Ovarian 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)
BRCA1 and BRCA2 (alterations (including mutations)); HRD (Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes and/or positive Genomic Instability Score)
RET (fusions)
NTRK1, NTRK2 and NTRK3 (fusions)
BRCA1 and BRCA2 (alterations (including mutations))
NTRK1, NTRK2 and NTRK3 (fusions)