Regulatory approval
Published by the Health Canada. Approved
Health Canada approved vemurafenib as a monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. A validated test is required to identify BRAF V600 mutation status.
This is written in the approval document as:
ZELBORAF (vemurafenib) is indicated as a monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. A validated test is required to identify BRAF V600 mutation status.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
Organizations
Biomarkers
Cancer types
Therapies
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HC (1) | BRAF p.V600E | Melanoma | Vemurafenib | |
| HC (1) | BRAF p.V600K | Melanoma | Vemurafenib |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-30 | Van Allen lab | Initial access of FDA approvals |