Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that CD33 + status confers therapeutic sensitivity to Gemtuzumab ozogamicin in patients with Acute Lymphoblastic Leukemia.

The U.S. Food and Drug Administration granted approval to gemtuzumab ozogamicin for the treatment of adult and pediatric patients aged 1 month or older with newly-diagnosed CD33-positive acute myeloid leukemia (AML).

This statement is based on a regulatory approval from the Food and Drug Administration:

MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older.

Citation

Wyeth Pharmaceuticals LLC. Mylotarg (gemtuzumab ozogamicin) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s004lbl.pdf. Revised June 2022. Accessed October 30, 2024. Wyeth Pharmaceuticals LLC. Mylotarg (gemtuzumab ozogamicin) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s004lbl.pdf. Revised June 2020. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2020-06-16	Food and Drug Administration	Indication received traditional approval.