Zelboraf (vemurafenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Genentech, Inc. Zelboraf (vemurafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202429s019lbl.pdf. Revised May 2020. Accessed October 30, 2024.

Regulatory approvals

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

Indication	Statements
ZELBORAF is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.	1
ZELBORAF is indicated for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.	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.V600E	Non-Langerhans Cell Histiocytosis/Erdheim-Chester Disease	Vemurafenib
Sensitivity (+)	BRAF p.V600K	Non-Langerhans Cell Histiocytosis/Erdheim-Chester Disease	Vemurafenib