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).

Lineage

Line of therapy

Approved indications, Acute lymphoblastic leukaemia
DrugBiomarker requirementRegimenSettingConditions
BCR::ABL18
Dasatinib
Sprycel, Dasatinib Accord Healthcare
+ chemotherapy
1L
Children and adolescents only
Imatinib
Glivec
Philadelphia chromosome (bcr-abl)
+ chemotherapy
1L
None
Ponatinib
Iclusig
Philadelphia chromosome (BCR::ABL1 translocation)
+ reduced-intensity chemotherapy
1L
None
Dasatinib
Sprycel, Dasatinib Accord Healthcare
Monotherapy
2L
Resistance or intolerance to prior therapy
Imatinib
Glivec
Philadelphia chromosome (bcr-abl)
Monotherapy
2L
Relapsed or refractory disease
Ponatinib
Iclusig
Philadelphia chromosome (BCR::ABL1 translocation)
Monotherapy
2L
Resistant to dasatinib, or intolerant to dasatinib and subsequent treatment with imatinib is not clinically appropriate
Blinatumomab
Blincyto
CD19-positive, Philadelphia chromosome-positive
Monotherapy
3L+
B-cell precursor ALL only; Failed treatment with at least 2 tyrosine kinase inhibitors (TKIs); No alternative treatment options
Ponatinib
Iclusig
T315I, Philadelphia chromosome-positive
Monotherapy
Any line
None

3 approvals for ALL need no biomarker and apply whatever the result. All approvals for ALL

See also

Label wording8

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Imatinib (Glivec)
    adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
  2. Imatinib (Glivec)
    adult patients with relapsed or refractory Ph+ ALL as monotherapy.
  3. Dasatinib (Sprycel, Dasatinib Accord Healthcare)
    Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
  4. Dasatinib (Sprycel, Dasatinib Accord Healthcare)
    newly diagnosed Ph+ ALL in combination with chemotherapy.
  5. Blinatumomab (Blincyto)
    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.
  6. Ponatinib (Iclusig)
    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.
  7. Ponatinib (Iclusig)
    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.
  8. Ponatinib (Iclusig)
    Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).