Regulatory approval
Published by the Health Canada.
Health Canada approved dabrafenib as a monotherapy, or in combination with trametinib, for the treatment of patients with the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
This is written in the approval document as:
TAFINLAR (dabrafenib mesylate) is indicated as a monotherapy, or in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BRAF p.V600E | Melanoma | Dabrafenib | |
| Sensitivity (+) | BRAF p.V600K | Melanoma | Dabrafenib |