# Enzalutamide

Enzalutamide (Xtandi, Astellas Pharma Europe B.V.) has 6 EU-approved indications in 1 tumour type.

## Approved indications

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 1st line, metastatic | Castration-resistant only; Failure of androgen deprivation therapy; Asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated |
| None | Monotherapy | 2nd line, metastatic | Castration-resistant only; Progressed on or after docetaxel therapy |
| None | + androgen deprivation therapy | Locally advanced | Hormone-sensitive only; High-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy |
| None | + androgen deprivation therapy | Metastatic | Hormone-sensitive only |
| None | Monotherapy | Locally advanced | Hormone-sensitive only; High-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy |
| None | Monotherapy | Locally advanced | Castration-resistant only; High-risk |

## Products

### Xtandi

- Company: Astellas Pharma Europe B.V.
- Target: Androgen receptor signalling inhibitor
- Class: Anti-androgens
- ATC: L02BB04
- EU approval: 21 Jun 2013
- Label revised: 29 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/xtandi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/xtandi
- Biosimilars and generics: Enzalutamide Viatris, Enzalutamide Accordpharma

Mechanism (SmPC section 5.1): Competitively blocks androgen binding to the androgen receptor, inhibiting receptor nuclear translocation and DNA association, decreasing prostate cancer cell growth; no agonist activity.

## Label wording

- **Enzalutamide** (Xtandi), Prostate cancer, locally advanced: “as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, locally advanced: “as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, metastatic: “in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, locally advanced: “for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, 1st line, metastatic: “for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, 2nd line, metastatic: “for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-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/enzalutamide