# Lapatinib

Lapatinib (Tyverb, Novartis Europharm Limited) 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 | + capecitabine | 2nd line, advanced | Progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting |
| HER2 IHC 3+ or IHC 2+/ISH-positive, HR-negative | + trastuzumab | 2nd line, metastatic | Progressed on prior trastuzumab therapy(ies) in combination with chemotherapy |
| HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive | + an aromatase inhibitor | Metastatic | Postmenopausal women; not currently intended for chemotherapy |

## Products

### Tyverb

- Company: Novartis Europharm Limited
- Target: Dual EGFR and HER2 kinase inhibitor
- Class: Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
- ATC: L01EH01
- EU approval: 10 Jun 2008
- Label revised: 6 Jan 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tyverb-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tyverb

Mechanism (SmPC section 5.1): Lapatinib inhibits the intracellular tyrosine kinase domains of both EGFR and HER2 receptors, thereby inhibiting ErbB-driven tumour cell growth.

## Label wording

- **Lapatinib** (Tyverb), Breast cancer, 2nd line, advanced: “in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf)
- **Lapatinib** (Tyverb), Breast cancer, 2nd line, metastatic: “in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf)
- **Lapatinib** (Tyverb), Breast cancer, metastatic: “in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tyverb-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/lapatinib