# Nilotinib

Nilotinib (Tasigna, Novartis Europharm Limited) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: BCR::ABL1 (3).

## Approved indications

### Chronic myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Philadelphia chromosome positive | Monotherapy | 1st line | Chronic phase |
| Philadelphia chromosome positive | Monotherapy | 2nd line | Resistance or intolerance to prior therapy including imatinib; Chronic phase or accelerated phase |
| Philadelphia chromosome positive | Monotherapy | 2nd line | Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase |

## Products

### Tasigna

- Company: Novartis Europharm Limited
- Target: BCR-ABL tyrosine kinase inhibitor
- Class: BCR-ABL tyrosine kinase inhibitors
- ATC: L01EA03
- EU approval: 19 Nov 2007
- Label revised: 17 Dec 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tasigna-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tasigna-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tasigna
- Biosimilars and generics: Nilotinib Accord

Mechanism (SmPC section 5.1): Nilotinib binds the ATP-binding site of the BCR-ABL oncoprotein, inhibiting its kinase activity to block proliferation and induce apoptosis in Philadelphia-chromosome positive leukaemia cells.

## Label wording

- **Nilotinib** (Tasigna), Chronic myeloid leukaemia, 1st line: “adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase,” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tasigna-epar-product-information_en.pdf)
- **Nilotinib** (Tasigna), Chronic myeloid leukaemia, 2nd line: “adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available,” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tasigna-epar-product-information_en.pdf)
- **Nilotinib** (Tasigna), Chronic myeloid leukaemia, 2nd line: “paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tasigna-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/nilotinib