# Darolutamide

Darolutamide (Nubeqa, Bayer AG) has 3 EU-approved indications in 1 tumour type.

## Approved indications

### Prostate cancer

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

## Products

### Nubeqa

- Company: Bayer AG
- Target: Androgen receptor inhibitor
- Class: Anti-androgens
- ATC: L02BB
- EU approval: 27 Mar 2020
- Label revised: 21 Aug 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/nubeqa-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/nubeqa-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/nubeqa

Mechanism (SmPC section 5.1): Binds the androgen receptor ligand-binding domain, competitively inhibiting androgen binding, AR nuclear translocation and AR-mediated transcription, decreasing prostate tumour cell proliferation.

## Label wording

- **Darolutamide** (Nubeqa), Prostate cancer, locally advanced: “- 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/nubeqa-epar-product-information_en.pdf)
- **Darolutamide** (Nubeqa), Prostate cancer, metastatic: “- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nubeqa-epar-product-information_en.pdf)
- **Darolutamide** (Nubeqa), Prostate cancer, metastatic: “- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nubeqa-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/darolutamide