Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRAF p.V600K status confers therapeutic sensitivity to Vemurafenib in patients with Melanoma.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.