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.

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.

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
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib