Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that HER2-negative and PR positive status confers therapeutic sensitivity to Abemaciclib, Fulvestrant in patients with Invasive Breast Carcinoma.

The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

Citation

Eli and Lily Company. Verzenio (abemaciclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf. Revised March 2023. Accessed October 30, 2024. 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.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2017-09-28	Food and Drug Administration	Indication received traditional approval.