# Apalutamide

Apalutamide (Erleada, Janssen-Cilag International NV) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + androgen deprivation therapy (ADT) | Metastatic | Hormone-sensitive only |
| None | Monotherapy | Locally advanced | Castration-resistant only; High risk of developing metastatic disease |

## Products

### Erleada

- Company: Janssen-Cilag International NV
- Target: Selective androgen receptor inhibitor
- Class: Anti-androgens
- ATC: L02BB05
- EU approval: 14 Jan 2019
- Label revised: 22 Apr 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/erleada-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/erleada

Mechanism (SmPC section 5.1): Binds the androgen receptor ligand-binding domain, preventing AR nuclear translocation, DNA binding and AR-mediated transcription, with no agonist activity; reduces tumour proliferation and increases apoptosis.

## Label wording

- **Apalutamide** (Erleada), Prostate cancer, locally advanced: “in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf)
- **Apalutamide** (Erleada), Prostate cancer, metastatic: “in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erleada-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/apalutamide