# Trastuzumab

Trastuzumab (Herceptin, Tuznue) has 10 EU-approved indications in 2 tumour types. Each needs a biomarker result: HER2 (10).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2 IHC 3+ or IHC 2+/ISH-positive | + neoadjuvant chemotherapy | Neoadjuvant | Then adjuvant monotherapy after surgery; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
| HER2 IHC 3+ or IHC 2+/ISH-positive | + docetaxel and carboplatin | Adjuvant, early | - |
| HER2 IHC 3+ or IHC 2+/ISH-positive | + paclitaxel or docetaxel | Adjuvant, early | After adjuvant chemotherapy with doxorubicin and cyclophosphamide |
| HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adjuvant, early | Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) Ambiguous in the label (treatment phase): check the SmPC. |
| HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adjuvant | After neoadjuvant Herceptin + chemotherapy and surgical resection; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
| HER2 IHC 3+ or IHC 2+/ISH-positive | + docetaxel | 1st line, metastatic | - |
| HER2 IHC 3+ or IHC 2+/ISH-positive | + paclitaxel | 1st line, metastatic | Anthracycline is not suitable |
| HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 3rd line+, metastatic | After at least two prior chemotherapy regimens for metastatic disease including an anthracycline and a taxane (unless unsuitable); failed hormonal therapy for hormone receptor-positive disease (unless unsuitable) |
| HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive | + aromatase inhibitor | Metastatic | No prior trastuzumab; Postmenopausal |

### Gastric and GEJ adenocarcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2 IHC 3+ or IHC 2+/ISH-positive | + capecitabine or 5-fluorouracil, and cisplatin | 1st line, metastatic | - |

## Products

### Tuznue

- Company: Prestige Biopharma Belgium
- Target: HER2-directed monoclonal antibody
- Class: HER2 (human epidermal growth factor receptor 2) inhibitors
- ATC: L01FD01
- EU approval: 19 Sep 2024
- Label revised: 14 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tuznue-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tuznue-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tuznue
- Biosimilars and generics: Kanjinti, Ontruzant, Zercepac, Herzuma, Herwenda, Trazimera, Dazublys, Ogivri

Mechanism (SmPC section 5.1): Binds HER2's extracellular domain to inhibit ligand-independent signalling, prevent extracellular domain cleavage, and mediate antibody-dependent cell-mediated cytotoxicity against HER2-overexpressing tumour cells.

### Herceptin

- Company: Roche Registration GmbH
- Target: HER2-directed monoclonal antibody
- Class: HER2 (human epidermal growth factor receptor 2) inhibitors
- ATC: L01FD01
- EU approval: 28 Aug 2000
- Label revised: 25 Nov 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/herceptin-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin
- Biosimilars and generics: Kanjinti, Ontruzant, Zercepac, Herzuma, Herwenda, Trazimera, Dazublys, Ogivri

Mechanism (SmPC section 5.1): Binds subdomain IV of HER2, inhibiting ligand-independent signalling, preventing extracellular domain cleavage, and mediating antibody-dependent cell-mediated cytotoxicity.

## Label wording

- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, 3rd line+, metastatic: “as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, 1st line, metastatic: “in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, 1st line, metastatic: “in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, metastatic: “in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant, early: “following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant, early: “following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant, early: “in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, neoadjuvant: “in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant: “in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Gastric and GEJ adenocarcinoma, 1st line, metastatic: “Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-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