MYLOTARG (gemtuzumab ozogamicin) is a conjugated monoclonal antibody used for the treatment of CD33-positive acute myeloid leukemia (AML). It is an intravenous formulation consisting of gemtuzumab, an anti-CD33 monoclonal antibody, conjugated with the cytotoxic agent ozogamicin. The drug works by targeting the CD33 antigen found on leukemia cells, delivering cytotoxic effects directly to the malignant cells, thereby inhibiting their growth. This mechanism helps in reducing the proliferation of leukemia cells in patients with AML.

MYLOTARG was first approved by the U.S. Food and Drug Administration (FDA) in 2000 and has undergone several updates to its prescribing information. In particular, it is noted for its potential to induce severe hepatotoxicity, including fatal hepatic veno-occlusive disease (VOD), which must be closely monitored during treatment. Clinical use of MYLOTARG requires careful consideration of patient history and liver function, as well as regular monitoring for any adverse events related to hepatic function.