Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized abemaciclib in combination with endocrine therapy and an aromatase inhibitor or fulvestrant as an initial endocrine-based therapy, or in women who have received prior endocrine therapy, for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Abemaciclib's product information further states that in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist. This indication is based on the randomized, double-blind, placebo-controlled phase 3 study MONARCH 3 that used either anastrozole or letrozole as an aromatase inhibitor.
This is written in the approval document as:
Verzenios is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
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, 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 | Invasive Breast Carcinoma | Abemaciclib, Fulvestrant | |
| Sensitivity (+) | HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib, Fulvestrant | |
| Sensitivity (+) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib, Fulvestrant |