Regulatory approval
Published by the European Medicines Agency.
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 is written in the approval document as:
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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BRAF p.V600E | Melanoma | Cobimetinib, Vemurafenib | |
| Sensitivity (+) | BRAF p.V600K | Melanoma | Cobimetinib, Vemurafenib |