Chronic myeloid leukaemia

The EU has approved 19 indications of 6 drugs in chronic myeloid leukaemia. Each needs a biomarker result: BCR::ABL1 (19).

Approved indications, Chronic myeloid leukaemia
Drug	Biomarker requirement	Regimen	Setting	Conditions

BCR::ABL119
Bosutinib Bosulif	Philadelphia chromosome / BCR::ABL1 translocation	Monotherapy	1L	Chronic phase only; Aged 6 years and older
Dasatinib Sprycel, Dasatinib Accord Healthcare		Monotherapy	1L	Chronic phase
Dasatinib Sprycel, Dasatinib Accord Healthcare		Monotherapy	1L	Children and adolescents only; Chronic phase
Imatinib Glivec	Philadelphia chromosome (bcr-abl)	Monotherapy	1L	Bone marrow transplantation is not considered as the first line of treatment
Nilotinib Tasigna	Philadelphia chromosome positive	Monotherapy	1L	Chronic phase
Bosutinib 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
Bosutinib 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
Dasatinib Sprycel, Dasatinib Accord Healthcare		Monotherapy	2L	Resistance or intolerance to prior therapy including imatinib; Chronic, accelerated or blast phase
Dasatinib Sprycel, Dasatinib Accord Healthcare		Monotherapy	2L	Resistance or intolerance to prior therapy; Lymphoid blast phase
Dasatinib Sprycel, Dasatinib Accord Healthcare		Monotherapy	2L	Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase
Nilotinib Tasigna	Philadelphia chromosome positive	Monotherapy	2L	Resistance or intolerance to prior therapy including imatinib; Chronic phase or accelerated phase
Nilotinib Tasigna	Philadelphia chromosome positive	Monotherapy	2L	Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase
Ponatinib 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
Ponatinib 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
Asciminib Scemblix	Philadelphia chromosome or BCR-ABL1 fusion	Monotherapy	Any line	Chronic phase only
Asciminib Scemblix	T315I, Philadelphia chromosome-positive	Monotherapy	Any line	Chronic phase only; Resistant to, intolerant to or ineligible for ponatinib
Imatinib Glivec	Philadelphia chromosome (bcr-abl)	Monotherapy	Any line	Failure of interferon-alpha therapy (for chronic phase)
Ponatinib Iclusig	T315I	Monotherapy	Any line	None
Ponatinib Iclusig	T315I	Monotherapy	Any line	Chronic phase only; Children and adolescents only; Aged 6 years or older

Biomarkers in chronic myeloid leukaemia

BCR::ABL119

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.