Cotellic (cobimetinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRAF p.V600E	Melanoma	Cobimetinib, Vemurafenib
Sensitivity (+)	BRAF p.V600K	Melanoma	Cobimetinib, Vemurafenib