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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (1)	BRAF p.V600E	Melanoma	Cobimetinib, Vemurafenib
FDA (1)	BRAF p.V600K	Melanoma	Cobimetinib, Vemurafenib