# BCR::ABL1 in acute lymphoblastic leukaemia

8 EU-approved indications in acute lymphoblastic leukaemia need a BCR::ABL1 result: imatinib (1st line), imatinib (2nd line), dasatinib (2nd line), dasatinib (1st line), blinatumomab (3rd line+), ponatinib (2nd line), ponatinib (any line) and ponatinib (1st line).

## Approved indications

### BCR::ABL1

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Dasatinib](https://oncolabels.com/drugs/dasatinib) (Sprycel, Dasatinib Accord Healthcare) | BCR::ABL1 fusion | + chemotherapy | 1st line | Children and adolescents only |
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | Philadelphia chromosome (bcr-abl) | + chemotherapy | 1st line | - |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | Philadelphia chromosome (BCR::ABL1 translocation) | + reduced-intensity chemotherapy | 1st line | - |
| [Dasatinib](https://oncolabels.com/drugs/dasatinib) (Sprycel, Dasatinib Accord Healthcare) | BCR::ABL1 fusion | Monotherapy | 2nd line | Resistance or intolerance to prior therapy |
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | Philadelphia chromosome (bcr-abl) | Monotherapy | 2nd line | Relapsed or refractory disease |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | Philadelphia chromosome (BCR::ABL1 translocation) | Monotherapy | 2nd line | Resistant to dasatinib, or intolerant to dasatinib and subsequent treatment with imatinib is not clinically appropriate |
| [Blinatumomab](https://oncolabels.com/drugs/blinatumomab) (Blincyto) | CD19-positive, Philadelphia chromosome-positive | Monotherapy | 3rd line+ | B-cell precursor ALL only; Failed treatment with at least 2 tyrosine kinase inhibitors (TKIs); No alternative treatment options |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | T315I, Philadelphia chromosome-positive | Monotherapy | Any line | - |

## Label wording

- **Imatinib** (Glivec), Acute lymphoblastic leukaemia, 1st line: “adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Acute lymphoblastic leukaemia, 2nd line: “adult patients with relapsed or refractory Ph+ ALL as monotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-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), 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)
- **Blinatumomab** (Blincyto), Acute lymphoblastic leukaemia, 3rd line+: “BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Acute lymphoblastic leukaemia, 2nd line: “Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Acute lymphoblastic leukaemia, any line: “Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Acute lymphoblastic leukaemia, 1st line: “Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-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/tumours/acute-lymphoblastic-leukaemia/bcr-abl1