# Lutetium (177Lu) vipivotide tetraxetan

Lutetium (177Lu) vipivotide tetraxetan (Pluvicto, Novartis Europharm Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: PSMA (1).

## Approved indications

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PSMA-positive | + androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition | 3rd line+, metastatic | Castration-resistant only; After AR pathway inhibition and taxane-based chemotherapy; Progressive disease |

## Products

### Pluvicto

- Company: Novartis Europharm Limited
- Target: PSMA-directed radioligand therapy
- ATC: V10XX
- EU approval: 9 Dec 2022
- Label revised: 20 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/pluvicto-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/pluvicto-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/pluvicto

Mechanism (SmPC section 5.1): Binds to PSMA on prostate cancer cells to deliver targeted beta-minus radiation from lutetium-177, causing DNA damage and cell death.

## Label wording

- **Lutetium (177Lu) vipivotide tetraxetan** (Pluvicto), Prostate cancer, 3rd line+, metastatic: “Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/pluvicto-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/lutetium-177lu-vipivotide-tetraxetan