Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. This indication is based on the monarchE (NCT03155997) clinical trial, which was a randomized (1:1), open-label, two cohort, multicenter study. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).

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

Verzenio is a kinase inhibitor indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence.

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/2023/208716s010s011lbl.pdf. Revised March 2023. Accessed October 6, 2026.

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Contributions

Date Contributor Description
2025-04-10 Van Allen lab Added propositions and statements for approval of abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for patients with HR+, HER2- breast cancer. Additional propositions are for combinations with letrozole, anastrozole, or exemestane per endocrine offerings within monarchE (NCT03155997).
2024-10-30 Van Allen lab Initial access of FDA approvals
2023-03-03 Food and Drug Administration Indication received traditional approval.