U.S. License Holder:
Wyeth Pharms. Inc.
Date of License:
September-01-2017
Last Update:
Dec-08-2024
FDA-Approved Indications
MYLOTARG (gemtuzumab ozogamicin) 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;
Treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.