Regulatory approval

Published by the Health Service Executive. Approved

Gemtuzumab ozogamicin is indicated for combination therapy with DAUNOrubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo CD33 positive Acute Myeloid Leukemia (AML), except acute promyelocytic leukaemia

This is written in the approval document.

Reimbursement

ODMS

Citation

Gemtuzumab ozogamicin DAUNOrubicin and cytarabine Therapy (AML induction), 2025, version number 2a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6992/612_v2a_Gemtuzumab_ozogamicin.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	CD33 +	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Gemtuzumab ozogamicin