Verzenio (abemaciclib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Eli and Lily Company. Verzenio (abemaciclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716Orig1s000lbl.pdf. Revised September 2017. Accessed October 6, 2026.

Regulatory approvals

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

Indication	Statements
Verzenio is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.	3
Verzenio is a kinase inhibitor indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Fulvestrant
FDA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Fulvestrant
FDA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib
FDA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib
FDA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib