Drug guidance
Gemtuzumab ozogamicin for untreated de novo CD33-positive acute myeloid leukaemia
Condition
Blood and Immune System
Cancer
1 June 2026
Published on 31 Aug 2022
Last Updated on 01 Jun 2026
Guidance Recommendations
The Ministry of Health's Drug Advisory Committee has recommended:
Gemtuzumab ozogamicin 5 mg powder for concentrate for solution for infusion in combination with daunorubicin and cytarabine for patients with previously untreated de novo CD33-positive acute myeloid leukaemia (AML), if they:
do not have acute promyelocytic leukaemia;
only start induction therapy while waiting for cytogenetic test results or after confirming favourable, intermediate or unknown (due to inconclusive test results) cytogenetic risk, and
start consolidation therapy after confirming favourable, intermediate, or unknown cytogenetic risk.
Funding status
Gemtuzumab ozogamicin 5 mg powder for concentrate for solution for infusion is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication from 1 September 2022.
Clinical indication, subsidy class and MediShield Life claims eligibility for gemtuzumab ozogamicin is provided in the Annex.
Gemtuzumab ozogamicin for untreated de novo CD33+ acute myeloid leukaemia (01 Jun 26) [PDF, 128 KB]