Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) CD33 + Acute Lymphoid Leukemia Gemtuzumab ozogamicin