Dasatinib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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 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 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