# BCR::ABL1

27 EU-approved indications of 7 drugs need a BCR::ABL1 result, in 2 tumour types, most of them in chronic myeloid leukaemia and acute lymphoblastic leukaemia.

## Approved indications by tumour

### Acute lymphoblastic leukaemia

| 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 | - |

### Chronic myeloid leukaemia

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Bosutinib](https://oncolabels.com/drugs/bosutinib) (Bosulif) | Philadelphia chromosome / BCR::ABL1 translocation | Monotherapy | 1st line | Chronic phase only; Aged 6 years and older |
| [Dasatinib](https://oncolabels.com/drugs/dasatinib) (Sprycel, Dasatinib Accord Healthcare) | BCR::ABL1 fusion | Monotherapy | 1st line | Chronic phase |
| [Dasatinib](https://oncolabels.com/drugs/dasatinib) (Sprycel, Dasatinib Accord Healthcare) | BCR::ABL1 fusion | Monotherapy | 1st line | Children and adolescents only; Chronic phase |
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | Philadelphia chromosome (bcr-abl) | Monotherapy | 1st line | Bone marrow transplantation is not considered as the first line of treatment |
| [Nilotinib](https://oncolabels.com/drugs/nilotinib) (Tasigna) | Philadelphia chromosome positive | Monotherapy | 1st line | Chronic phase |
| [Bosutinib](https://oncolabels.com/drugs/bosutinib) (Bosulif) | 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 |
| [Bosutinib](https://oncolabels.com/drugs/bosutinib) (Bosulif) | 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 |
| [Dasatinib](https://oncolabels.com/drugs/dasatinib) (Sprycel, Dasatinib Accord Healthcare) | BCR::ABL1 fusion | Monotherapy | 2nd line | Resistance or intolerance to prior therapy including imatinib; Chronic, accelerated or blast phase |
| [Dasatinib](https://oncolabels.com/drugs/dasatinib) (Sprycel, Dasatinib Accord Healthcare) | BCR::ABL1 fusion | Monotherapy | 2nd line | Resistance or intolerance to prior therapy; Lymphoid blast phase |
| [Dasatinib](https://oncolabels.com/drugs/dasatinib) (Sprycel, Dasatinib Accord Healthcare) | BCR::ABL1 fusion | Monotherapy | 2nd line | Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase |
| [Nilotinib](https://oncolabels.com/drugs/nilotinib) (Tasigna) | Philadelphia chromosome positive | Monotherapy | 2nd line | Resistance or intolerance to prior therapy including imatinib; Chronic phase or accelerated phase |
| [Nilotinib](https://oncolabels.com/drugs/nilotinib) (Tasigna) | Philadelphia chromosome positive | Monotherapy | 2nd line | Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | BCR::ABL1 fusion (defines the disease) | Monotherapy | 2nd line | Resistant to dasatinib or nilotinib, or intolerant to dasatinib or nilotinib and subsequent treatment with imatinib is not clinically appropriate |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | BCR::ABL1 fusion (defines the disease) | Monotherapy | 2nd line | Chronic phase only; Children and adolescents only; Resistant to dasatinib or nilotinib, or intolerant to dasatinib or nilotinib and subsequent treatment with imatinib is not clinically appropriate; Aged 6 years or older |
| [Asciminib](https://oncolabels.com/drugs/asciminib) (Scemblix) | Philadelphia chromosome or BCR-ABL1 fusion | Monotherapy | Any line | Chronic phase only |
| [Asciminib](https://oncolabels.com/drugs/asciminib) (Scemblix) | T315I, Philadelphia chromosome-positive | Monotherapy | Any line | Chronic phase only; Resistant to, intolerant to or ineligible for ponatinib |
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | Philadelphia chromosome (bcr-abl) | Monotherapy | Any line | Failure of interferon-alpha therapy (for chronic phase) |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | BCR::ABL1 T315I | Monotherapy | Any line | - |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | BCR::ABL1 T315I | Monotherapy | Any line | Chronic phase only; Children and adolescents only; Aged 6 years or older |

## Label wording

- **Imatinib** (Glivec), Chronic myeloid leukaemia, 1st line: “adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Chronic myeloid leukaemia, any line: “adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **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), 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)
- **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)
- **Asciminib** (Scemblix), Chronic myeloid leukaemia, any line: “Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf)
- **Asciminib** (Scemblix), Chronic myeloid leukaemia, any line: “Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Chronic myeloid leukaemia, 2nd line: “chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib 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), Chronic myeloid leukaemia, any line: “chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib 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, 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)
- **Ponatinib** (Iclusig), Chronic myeloid leukaemia, 2nd line: “chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib 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), Chronic myeloid leukaemia, any line: “chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib 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)
- **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)
- **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/biomarkers/bcr-abl1