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).
Phase
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BCR::ABL119 | ||||
Bosulif | Philadelphia chromosome / BCR::ABL1 translocation | Monotherapy | 1L | Chronic phase only; Aged 6 years and older |
Sprycel, Dasatinib Accord Healthcare | Monotherapy | 1L | Chronic phase | |
Sprycel, Dasatinib Accord Healthcare | Monotherapy | 1L | Children and adolescents only; Chronic phase | |
Glivec | Philadelphia chromosome (bcr-abl) | Monotherapy | 1L | Bone marrow transplantation is not considered as the first line of treatment |
Tasigna | Philadelphia chromosome positive | Monotherapy | 1L | Chronic phase |
Bosulif | Philadelphia chromosome / BCR::ABL1 translocation | Monotherapy | 2L | 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 |
Bosulif | Philadelphia chromosome / BCR::ABL1 translocation | Monotherapy | 2L | 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 |
Sprycel, Dasatinib Accord Healthcare | Monotherapy | 2L | Resistance or intolerance to prior therapy including imatinib; Chronic, accelerated or blast phase | |
Sprycel, Dasatinib Accord Healthcare | Monotherapy | 2L | Resistance or intolerance to prior therapy; Lymphoid blast phase | |
Sprycel, Dasatinib Accord Healthcare | Monotherapy | 2L | Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase | |
Tasigna | Philadelphia chromosome positive | Monotherapy | 2L | Resistance or intolerance to prior therapy including imatinib; Chronic phase or accelerated phase |
Tasigna | Philadelphia chromosome positive | Monotherapy | 2L | Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase |
Iclusig | Defines the disease | Monotherapy | 2L | Resistant to dasatinib or nilotinib, or intolerant to dasatinib or nilotinib and subsequent treatment with imatinib is not clinically appropriate |
Iclusig | Defines the disease | Monotherapy | 2L | 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 |
Scemblix | Philadelphia chromosome or BCR-ABL1 fusion | Monotherapy | Any line | Chronic phase only |
Scemblix | T315I, Philadelphia chromosome-positive | Monotherapy | Any line | Chronic phase only; Resistant to, intolerant to or ineligible for ponatinib |
Glivec | Philadelphia chromosome (bcr-abl) | Monotherapy | Any line | Failure of interferon-alpha therapy (for chronic phase) |
Iclusig | T315I | Monotherapy | Any line | None |
Iclusig | T315I | Monotherapy | Any line | Chronic phase only; Children and adolescents only; Aged 6 years or older |
See also
Label wording19
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Imatinib (Glivec)
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.
- Imatinib (Glivec)
adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
- Dasatinib (Sprycel, Dasatinib Accord Healthcare)
newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
- Dasatinib (Sprycel, Dasatinib Accord Healthcare)
chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.
- Dasatinib (Sprycel, Dasatinib Accord Healthcare)
Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
- Dasatinib (Sprycel, Dasatinib Accord Healthcare)
newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
- Dasatinib (Sprycel, Dasatinib Accord Healthcare)
newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
- Asciminib (Scemblix)
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).
- Asciminib (Scemblix)
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).
- Ponatinib (Iclusig)
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
- Ponatinib (Iclusig)
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
- Ponatinib (Iclusig)
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.
- Ponatinib (Iclusig)
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.
- Bosutinib (Bosulif)
Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
- Bosutinib (Bosulif)
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.
- Bosutinib (Bosulif)
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.
- Nilotinib (Tasigna)
adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase,
- Nilotinib (Tasigna)
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,
- Nilotinib (Tasigna)
paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.