Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Vemurafenib's product information states the special warning and caution that the efficacy and safety of vemurafenib in patients with tumors expressing rare BRAF V600 mutations other than V600E and V600K have not been convincingly established.

This is written in the approval document as:

Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation- positive unresectable or metastatic melanoma.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BRAF p.V600E	Melanoma	Vemurafenib
EMA (1)	BRAF p.V600K	Melanoma	Vemurafenib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2012-02-17	European Medicines Agency	Indication received approval from the European Commission.