Regulatory approval

Published by the Food and Drug Administration. Approved

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 is written in the approval document as:

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	CD33 +	Acute Lymphoblastic Leukemia	Gemtuzumab ozogamicin

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.