Mylotarg (gemtuzumab ozogamicin) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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