Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to cobimetinib in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

This is written in the approval document as:

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.

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.

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