# Palbociclib

Palbociclib (Ibrance, Pfizer Europe MA EEIG) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: Hormone receptor (2).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Hormone receptor-positive, HER2-negative | + fulvestrant | 2nd line, advanced | After prior endocrine therapy; Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist |
| Hormone receptor-positive, HER2-negative | + an aromatase inhibitor | Advanced | In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist |

## Products

### Ibrance

- Company: Pfizer Europe MA EEIG
- Target: CDK4/6 inhibitor
- Class: Cyclin-dependent kinase (CDK) inhibitors
- ATC: L01EF01
- EU approval: 9 Nov 2016
- Label revised: 7 Mar 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/ibrance-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/ibrance-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ibrance
- Biosimilars and generics: Palbociclib Viatris

Mechanism (SmPC section 5.1): Palbociclib is a selective, reversible inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which act downstream of multiple signalling pathways leading to cellular proliferation.

## Label wording

- **Palbociclib** (Ibrance), Breast cancer, advanced: “IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor;” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ibrance-epar-product-information_en.pdf)
- **Palbociclib** (Ibrance), Breast cancer, 2nd line, advanced: “IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
- in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ibrance-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/palbociclib