Drug guidance
Blinatumomab for treating relapsed or refractory B-precursor acute lymphoblastic leukaemia
Condition
Blood and Immune System
Cancer
4 January 2022
Published on 01 Sep 2020
Last Updated on 04 Jan 2022
Guidance Recommendations
The Ministry of Health’s Drug Advisory Committee has recommended:
Blinatumomab powder for infusion 35 mcg/vial for treating relapsed or refractory B-precursor acute lymphoblastic leukaemia (r/r B-ALL) 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.
Subsidy status
Blinatumomab powder for infusion 35mcg/vial is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication.
Blinatumomab for treating relapsed or refractory B-ALL (4 Jan 2022) [PDF, 177 KB]