# Pertuzumab

Pertuzumab (Perjeta, Roche Registration GmbH ) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: HER2 (3).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Neoadjuvant | Locally advanced, inflammatory, or early stage; high risk of recurrence |
| HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Adjuvant, early | High risk of recurrence |
| HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and docetaxel | 1st line, advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |

## Products

### Perjeta

- Company: Roche Registration GmbH 
- Target: HER2-targeted monoclonal antibody
- Class: HER2 (human epidermal growth factor receptor 2) inhibitors
- ATC: L01FD02
- EU approval: 4 Mar 2013
- Label revised: 28 Apr 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/perjeta-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/perjeta
- Biosimilars and generics: Poherdy

Mechanism (SmPC section 5.1): Pertuzumab binds the dimerization domain of HER2, blocking heterodimerisation with other HER family receptors to inhibit downstream MAP kinase and PI3K signalling, while also mediating ADCC.

## Label wording

- **Pertuzumab** (Perjeta), Breast cancer, neoadjuvant: “the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf)
- **Pertuzumab** (Perjeta), Breast cancer, adjuvant, early: “the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf)
- **Pertuzumab** (Perjeta), Breast cancer, 1st line, advanced: “Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/perjeta-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/pertuzumab