Dasatinib

Dasatinib (Dasatinib Accord Healthcare, Sprycel) has 7 EU-approved indications in 2 tumour types. Each needs a biomarker result: BCR::ABL1 (7).
Approved indications of Dasatinib
Biomarker requirementRegimenSettingConditions
Acute lymphoblastic leukaemia2
BCR::ABL1 fusion
+ chemotherapy
1L
Children and adolescents only
BCR::ABL1 fusion
Monotherapy
2L
Resistance or intolerance to prior therapy
Chronic myeloid leukaemia5
BCR::ABL1 fusion
Monotherapy
1L
Chronic phase
BCR::ABL1 fusion
Monotherapy
1L
Children and adolescents only; Chronic phase
BCR::ABL1 fusion
Monotherapy
2L
Resistance or intolerance to prior therapy including imatinib; Chronic, accelerated or blast phase
BCR::ABL1 fusion
Monotherapy
2L
Resistance or intolerance to prior therapy; Lymphoid blast phase
BCR::ABL1 fusion
Monotherapy
2L
Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase
Full text of section 4.1 (therapeutic indications)
Sprycel

SPRYCEL is indicated for the treatment of adult patients with: ▪ newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. ▪ chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. ▪ Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. SPRYCEL is indicated for the treatment of paediatric patients with: ▪ newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. ▪ newly diagnosed Ph+ ALL in combination with chemotherapy. ▪ newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. ▪ newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.

Dasatinib Accord Healthcare

Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: ▪ newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. ▪ chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. ▪ Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: ▪ newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. ▪ newly diagnosed Ph+ ALL in combination with chemotherapy.

Label history

54 changes to the Sprycel label since 2007, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Product

Changes