Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

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