# Trastuzumab emtansine

Trastuzumab emtansine (Kadcyla, Roche Registration GmbH) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: HER2 (2).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adjuvant, early | After neoadjuvant taxane-based and HER2-targeted therapy; Residual invasive disease, in the breast and/or lymph nodes |
| HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2nd line, advanced | After prior trastuzumab and a taxane, separately or in combination; and either prior therapy for locally advanced or metastatic disease, or disease recurrence during or within six months of completing adjuvant therapy |

## Products

### Kadcyla

- Company: Roche Registration GmbH
- Target: HER2-directed antibody-drug conjugate
- Class: HER2 (human epidermal growth factor receptor 2) inhibitors
- ATC: L01FD03
- EU approval: 15 Nov 2013
- Label revised: 16 Jun 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/kadcyla-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/kadcyla

Mechanism (SmPC section 5.1): Binds HER2, undergoes internalisation to release the microtubule inhibitor DM1, which inhibits tubulin polymerisation, arresting cells in G2/M phase and inducing apoptosis.

## Label wording

- **Trastuzumab emtansine** (Kadcyla), Breast cancer, adjuvant, early: “Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf)
- **Trastuzumab emtansine** (Kadcyla), Breast cancer, 2nd line, advanced: “Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kadcyla-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-emtansine