Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
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.