Braftovi (encorafenib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Encorafenib is indicated in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.	2
Encorafenib is indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.	1
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRAF p.V600E	Melanoma	Binimetinib, Encorafenib
Sensitivity (+)	BRAF p.V600K	Melanoma	Binimetinib, Encorafenib
Sensitivity (+)	BRAF p.V600E	Colorectal Adenocarcinoma	Cetuximab, Encorafenib
Sensitivity (+)	BRAF p.V600E	Non-Small Cell Lung Cancer	Binimetinib, Encorafenib