MAFBlinatumomab (Blincyto) Infusion 35 mcg
1) Treatment of B-precursor acute lymphoblastic leukaemia in first or subsequent complete remission with minimal residual disease (MRD) for:
– up to a maximum of one cycle for induction in a lifetime;
– and up to three additional cycles for consolidation in a lifetime.
Complete remission is defined as a patient who:
a) has 5% or less bone marrow blasts; and
b) has no evidence of disease; and
c) has a full recovery of peripheral blood counts with platelet count of more than 100,000 per microlitre; and
d) has absolute neutrophil count of more than 1,000 per microlitre.
2) Treatment of relapsed or refractory B-precursor acute lymphoblastic leukaemia for:
– up to a maximum of two cycles for induction in a lifetime; and
– up to three additional cycles for consolidation in a lifetime in patients who achieve a complete response after induction.
Patients with Philadelphia chromosome positive disease must have previously received a tyrosine kinase inhibitor before receiving blinatumomab.
Patients must not have received blinatumomab previously for the treatment of minimal residual disease (MRD)-positive B-ALL OR patients must have had a relapse-free period of at least six months following completion of treatment with blinatumomab for MRD.
Complete response is defined as a patient who:
– has 5% or less bone marrow blasts; and
– has no evidence of disease; and
– has platelet count of more than 50,000 per microlitre; and
– has absolute neutrophil count of more than 500 per microlitre.