Regulatory approval

Published by the Food and Drug Administration. Approved

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 is written in the approval document as:

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Tamoxifen
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Tamoxifen
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Tamoxifen
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Anastrozole
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Anastrozole
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Anastrozole
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Letrozole
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Letrozole
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Letrozole
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Exemestane
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Exemestane
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Exemestane

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.