# Dasatinib

Dasatinib (Dasatinib Accord Healthcare, Sprycel) has 7 EU-approved indications in 2 tumour types. Each needs a biomarker result: BCR::ABL1 (7).

## Approved indications

### Acute lymphoblastic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BCR::ABL1 fusion | + chemotherapy | 1st line | Children and adolescents only |
| BCR::ABL1 fusion | Monotherapy | 2nd line | Resistance or intolerance to prior therapy |

### Chronic myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BCR::ABL1 fusion | Monotherapy | 1st line | Chronic phase |
| BCR::ABL1 fusion | Monotherapy | 1st line | Children and adolescents only; Chronic phase |
| BCR::ABL1 fusion | Monotherapy | 2nd line | Resistance or intolerance to prior therapy including imatinib; Chronic, accelerated or blast phase |
| BCR::ABL1 fusion | Monotherapy | 2nd line | Resistance or intolerance to prior therapy; Lymphoid blast phase |
| BCR::ABL1 fusion | Monotherapy | 2nd line | Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase |

## Products

### Sprycel

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: BCR-ABL and SRC kinase inhibitor
- Class: BCR-ABL tyrosine kinase inhibitors
- ATC: L01EA02
- EU approval: 20 Nov 2006
- Label revised: 2 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/sprycel-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/sprycel

Mechanism (SmPC section 5.1): Dasatinib inhibits BCR-ABL and SRC family kinases at subnanomolar concentrations, overcoming imatinib resistance and inhibiting leukaemic disease progression.

### Dasatinib Accord Healthcare

- Company: Accord Healthcare S.L.U.
- Target: BCR-ABL/SRC kinase inhibitor
- Class: BCR-ABL tyrosine kinase inhibitors
- ATC: L01EA02
- EU approval: 26 Jul 2024
- Label revised: 5 Feb 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/dasatinib-accord-healthcare-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/dasatinib-accord-healthcare-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accord-healthcare

Mechanism (SmPC section 5.1): Dasatinib inhibits SRC family kinases (incl. LYN, HCK) at subnanomolar levels and acts against BCR-ABL-driven leukaemic cells, overcoming several mechanisms of imatinib resistance.

## Label wording

- **Dasatinib** (Sprycel, Dasatinib Accord Healthcare), Chronic myeloid leukaemia, 1st line: “newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf)
- **Dasatinib** (Sprycel, Dasatinib Accord Healthcare), Chronic myeloid leukaemia, 2nd line: “chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf)
- **Dasatinib** (Sprycel, Dasatinib Accord Healthcare), Acute lymphoblastic leukaemia, 2nd line: “Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf)
- **Dasatinib** (Sprycel, Dasatinib Accord Healthcare), Chronic myeloid leukaemia, 2nd line: “Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf)
- **Dasatinib** (Sprycel, Dasatinib Accord Healthcare), Chronic myeloid leukaemia, 1st line: “newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf)
- **Dasatinib** (Sprycel, Dasatinib Accord Healthcare), Chronic myeloid leukaemia, 2nd line: “newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf)
- **Dasatinib** (Sprycel, Dasatinib Accord Healthcare), Acute lymphoblastic leukaemia, 1st line: “newly diagnosed Ph+ ALL in combination with chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sprycel-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/dasatinib