Regulatory approval

Published by the European Medicines Agency. Approved

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

This is written in the approval document.

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.

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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 Vemurafenib
EMA (1) BRAF p.V600K Melanoma Vemurafenib