# BCR::ABL1 in chronic myeloid leukaemia 19 EU-approved indications in chronic myeloid leukaemia need a BCR::ABL1 result: imatinib (1st line), imatinib (any line), dasatinib (1st line), dasatinib (2nd line), dasatinib (2nd line), dasatinib (1st line), dasatinib (2nd line), asciminib (any line), asciminib (any line), ponatinib (2nd line), ponatinib (any line), ponatinib (2nd line), ponatinib (any line), bosutinib (1st line), bosutinib (2nd line), bosutinib (2nd line), nilotinib (1st line), nilotinib (2nd line) and nilotinib (2nd line). ## Approved indications ### BCR::ABL1 | 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) - **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), 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) - **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), 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/tumours/chronic-myeloid-leukaemia/bcr-abl1