Regulatory approval

Published by the Health Canada.

Health Canada approved gemtuzumab ozogamicin in combination with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia.

This is written in the approval document as:

Mylotarg (gemtuzumab ozogamicin for injection) is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia.

Citation

Pfizer Canada ULC. Mylotarg (gemtuzumab ozogamicin) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00069427.PDF. Revised February 2023. Accessed June 2025.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	CD33 +	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Gemtuzumab ozogamicin