Regulatory approval

Published by the European Medicines Agency. Approved

Verzenios in combination with endocrine therapy is indicated 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 Lilly Nederland B.V. Verzenios (abemaciclib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf. Revised March 2024. Accessed March 25, 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
EMA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Tamoxifen
EMA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
EMA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
EMA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Anastrozole
EMA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
EMA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
EMA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Letrozole
EMA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
EMA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
EMA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane
EMA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Exemestane
EMA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2022-04-01 European Medicines Agency Indication received approval from the European Commission.