Regulatory approval

Published by the Food and Drug Administration. Approved

COTELLIC is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.

This is written in the approval document.

Citation

Genentech USA, Inc. Cotellic (cobimetinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206192s006lbl.pdf. Revised May 2023. Accessed October 30, 2024.

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Therapeutic response

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

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