Zelboraf (vemurafenib) [product information]. EMA.
Regulatory approval published by the European Medicines Agency.
Citation
Roche Registration GmbH. Zelboraf (vemurafenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/zelboraf-epar-product-information_en.pdf. Revised July 2023. Accessed March 26, 2024.Regulatory approvals
Approved indications from this document for cancer drugs containing at least one biomarker.
| Indication | Statements |
|---|---|
| Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation- positive unresectable or metastatic melanoma. | 2 |
Therapeutic response
Precision oncology relationships for therapeutic response derived from this document.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BRAF p.V600E | Melanoma | Vemurafenib | |
| Sensitivity (+) | BRAF p.V600K | Melanoma | Vemurafenib |