# Abemaciclib

Abemaciclib (Verzenios, Eli Lilly Nederland B.V.) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: Hormone receptor (3).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Hormone receptor-positive, HER2-negative | + endocrine therapy | Adjuvant, early | Node-positive; high risk of recurrence; In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist |
| Hormone receptor-positive, HER2-negative | + an aromatase inhibitor or fulvestrant | 1st line, advanced | Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist |
| Hormone receptor-positive, HER2-negative | + an aromatase inhibitor or fulvestrant | 2nd line, advanced | After prior endocrine therapy; Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist |

## Products

### Verzenios

- Company: Eli Lilly Nederland B.V.
- Target: CDK4/6 inhibitor
- Class: Cyclin-dependent kinase (CDK) inhibitors
- ATC: L01EF03
- EU approval: 26 Sep 2018
- Label revised: 25 Aug 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/verzenios-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/verzenios

Mechanism (SmPC section 5.1): Inhibits CDK4 and CDK6, blocking retinoblastoma protein phosphorylation and arresting cell cycle progression from the G1 to the S phase to suppress tumour growth.

## Label wording

- **Abemaciclib** (Verzenios), Breast cancer, adjuvant, early: “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 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf)
- **Abemaciclib** (Verzenios), Breast cancer, 1st line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf)
- **Abemaciclib** (Verzenios), Breast cancer, 2nd line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/abemaciclib