# Bosutinib

Bosutinib (Bosulif, Pfizer Europe MA EEIG) 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 / BCR::ABL1 translocation | Monotherapy | 1st line | Chronic phase only; Aged 6 years and older |
| Philadelphia chromosome / BCR::ABL1 translocation | Monotherapy | 2nd line | Chronic phase only; Previously treated with one or more tyrosine kinase inhibitor(s); Aged 6 years and older; imatinib, nilotinib and dasatinib are not considered appropriate treatment options |
| Philadelphia chromosome / BCR::ABL1 translocation | Monotherapy | 2nd line | Accelerated or blast phase only; Previously treated with one or more tyrosine kinase inhibitor(s); Imatinib, nilotinib and dasatinib are not considered appropriate treatment options |

## Products

### Bosulif

- Company: Pfizer Europe MA EEIG
- Target: BCR-ABL and Src family kinase inhibitor
- Class: BCR-ABL tyrosine kinase inhibitors
- ATC: L01EA04
- EU approval: 27 Mar 2013
- Label revised: 12 Jan 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/bosulif-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/bosulif-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/bosulif

Mechanism (SmPC section 5.1): Bosutinib binds the kinase domain of the abnormal BCR-ABL kinase and also inhibits Src family kinases (Src, Lyn, Hck), suppressing proliferation and survival of CML and Ph+ ALL cells.

## Label wording

- **Bosutinib** (Bosulif), Chronic myeloid leukaemia, 1st line: “Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/bosulif-epar-product-information_en.pdf)
- **Bosutinib** (Bosulif), Chronic myeloid leukaemia, 2nd line: “Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/bosulif-epar-product-information_en.pdf)
- **Bosutinib** (Bosulif), Chronic myeloid leukaemia, 2nd line: “Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/bosulif-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/bosutinib