Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized binimetinib in combination with encorafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
This is written in the approval document as:
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Citation
Pierre Fabre Medicament. Mektovi (binimetinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/mektovi-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 |