# Neratinib

Neratinib (Nerlynx, Pierre Fabre Medicament) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: HER2 (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive | Monotherapy | Adjuvant, early | After adjuvant trastuzumab-based therapy completed less than one year ago |

## Products

### Nerlynx

- Company: Pierre Fabre Medicament
- Target: Irreversible pan-HER tyrosine kinase inhibitor
- Class: Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
- ATC: L01EH02
- EU approval: 31 Aug 2018
- Label revised: 27 Oct 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/nerlynx-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/nerlynx-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/nerlynx

Mechanism (SmPC section 5.1): Covalently and irreversibly binds the ATP site of EGFR, HER2 and HER4, reducing receptor autophosphorylation and downstream MAPK/AKT signalling and inhibiting tumour cell proliferation.

## Label wording

- **Neratinib** (Nerlynx), Breast cancer, adjuvant, early: “Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nerlynx-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/neratinib