# Datopotamab deruxtecan

Datopotamab deruxtecan (Datroway, Daiichi Sankyo Europe GmbH) has 2 EU-approved indications in 2 tumour types. 1 needs a biomarker result: Hormone receptor (1).

## Approved indications

### Triple-negative breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Triple-negative (ER-negative, PR-negative, HER2-negative) | Monotherapy | 1st line, advanced | Not candidates for PD-1/PD-L1 inhibitor therapy |

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Hormone receptor-positive, HER2-negative | Monotherapy | 2nd line, advanced | After endocrine therapy and at least one line of chemotherapy in the advanced setting |

## Products

### Datroway

- Company: Daiichi Sankyo Europe GmbH
- Target: TROP2-directed antibody-drug conjugate
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX35
- EU approval: 4 Apr 2025
- Label revised: 30 Sep 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/datroway-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/datroway-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/datroway

Mechanism (SmPC section 5.1): Binds to TROP2 on tumor cells and internalises, releasing a topoisomerase I inhibitor payload that induces DNA damage and apoptotic cell death.

## Label wording

- **Datopotamab deruxtecan** (Datroway), Triple-negative breast cancer, 1st line, advanced: “Datroway as monotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/datroway-epar-product-information_en.pdf)
- **Datopotamab deruxtecan** (Datroway), Breast cancer, 2nd line, advanced: “Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/datroway-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/datopotamab-deruxtecan