Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Cobimetinib, Vemurafenib in patients with Melanoma.

The European Medicines Agency (EMA) has authorized cobimetinib in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF p.V600 variant.

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

Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Citation

Roche Registration GmbH. Cotellic (cobimetinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/cotellic-epar-product-information_en.pdf. Revised March 2023. Accessed March 6, 2024.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2015-11-20	European Medicines Agency	Indication received approval from the European Commission.