Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized abemaciclib in combination with endocrine therapy 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. Abemaciclib's product information further states that in pre- or perimenopausal women, aromatase inhibitor endrocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. The product information further states that this indication was approved based on results from the monarchE study, a randomized, open label, two cohort, phase 3 study which enrolled a total of 5,637 patients who were randomized in a 1:1 ratio to receive 2 years of abemaciclib plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).

This is written in the approval document as:

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.

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.

View API

Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Tamoxifen
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Anastrozole
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Letrozole
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Exemestane
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane