Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized encorafenib in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant. The efficacy and safety of encorafenib have been established only in patients with melanoma tumours expressing BRAF V600E and V600K variants or colorectal tumours expressing BRAF V600E.
This is written in the approval document as:
Encorafenib is indicated in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Citation
Pierre Fabre Medicament. Braftovi (encorafenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf. Revised September 2024. Accessed October 20, 2024.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 | Binimetinib, Encorafenib | |
| Sensitivity (+) | BRAF p.V600K | Melanoma | Binimetinib, Encorafenib |