# Trastuzumab deruxtecan

Trastuzumab deruxtecan (Enhertu, Daiichi Sankyo Europe GmbH) has 7 EU-approved indications in 4 tumour types. Each needs a biomarker result: HER2 (7).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2 mutation | Monotherapy | 2nd line, advanced | After platinum-based chemotherapy with or without immunotherapy |

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2 IHC 3+ or IHC 2+/ISH-positive | + pertuzumab | 1st line, advanced | - |
| HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2nd line, advanced | After one or more prior anti-HER2-based regimens |
| IHC 1+ or IHC 2+/ISH-negative or IHC 0 with membrane staining (faint, incomplete, ≤10% of tumour cells), HER2-low or HER2-ultralow, HR-positive | Monotherapy | 2nd line, advanced | After at least one endocrine therapy in the metastatic setting; Not considered suitable for endocrine therapy as the next line of treatment |
| IHC 1+ or IHC 2+/ISH-negative, HER2-low | Monotherapy | 2nd line, advanced | After prior chemotherapy in the metastatic setting or disease recurrence during or within 6 months of completing adjuvant chemotherapy |

### Gastric and GEJ adenocarcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2nd line, advanced | After prior trastuzumab-based regimen |

### Solid tumours, tumour-agnostic

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

## Products

### Enhertu

- Company: Daiichi Sankyo Europe GmbH
- Target: HER2-directed antibody-drug conjugate
- Class: HER2 (human epidermal growth factor receptor 2) inhibitors
- ATC: L01FD04
- EU approval: 18 Jan 2021
- Label revised: 20 Oct 2026
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/enhertu-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/enhertu

Mechanism (SmPC section 5.1): Binds to HER2 on tumour cells, internalises, and releases a topoisomerase I inhibitor payload that induces DNA damage and apoptotic cell death.

## Label wording

- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 1st line, advanced: “Enhertu in combination with pertuzumab is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 2nd line, advanced: “Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 2nd line, advanced: “• hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 2nd line, advanced: “• HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Non-small cell lung cancer, 2nd line, advanced: “Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Gastric and GEJ adenocarcinoma, 2nd line, advanced: “Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Solid tumours, tumour-agnostic, 2nd line, advanced: “Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options (see sections 4.4 and 5.1; for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-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/trastuzumab-deruxtecan