Melanoma
Melanoma is an aggressive skin cancer originating from melanocytes. Key genomic alterations such as BRAF mutations play a central role in therapeutic selection.
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 Melanoma in FDA labeling.
| Biomarker | Biomarker criteria | Therapies |
|---|---|---|
| BRAF |
| |
| BRAF |
| |
| BRAF |
| |
| BRAF |
|
Defined at the solid tumor level and applicable to Melanoma and other solid tumor cancers.
Therapies with biomarker-defined approvals
Each therapy below has at least one FDA companion diagnostic approval tied to Melanoma. Select a therapy to view the specific approval and eligible tests.
BRAF (V600E and V600K)
BRAF (V600E and V600K); BRAF (V600E or V600K)
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)
BRAF (V600E and V600K); BRAF (V600E or V600K)
RET (fusions)
NTRK1, NTRK2 and NTRK3 (fusions)
BRAF (V600E)
BRAF (V600E and V600K)
BRAF (V600)
NTRK1, NTRK2 and NTRK3 (fusions)
BRAF (V600E)