Generic Name: gemtuzumab ozogamicin

Pronunciation: N/A

Abbreviation: N/A

Other Market Name: N/A

Drug Class: Targeted Therapy Medications

Company: Pfizer/Wyeth

Approval Status: Approved

Generic Version Available: No

Experimental Code: N/A

Drug Indication

Mylotarg is a CD33-directed antibody-drug conjugate approved for adults and children with newly diagnosed or relapsed or refractory acute myeloid leukemia.

General Info

Mylotarg consists of an antibody that binds to the CD33 receptor protein on malignant B cells combined with a chemotherapy drug. This antibody delivers the cytotoxic drug directly to cancer cells, which reduces harm to normal cells. The drug inhibits cell division and causes apoptosis (cell suicide).

Clinical trials showed that Mylotarg plus chemotherapy delayed disease progression more than chemotherapy alone in people with relapsed or refractory (nonresponsive) acute myeloid leukemia. The MyloFrance study showed that 26% of people with newly diagnosed acute myeloid leukemia experienced complete remission, with a median relapse-free survival duration of 11.6 months. A study of newly diagnosed childrnen and young adults with AML found that 48% were free of induction failure, relapse or death at five years. Mylotarg was first approved in 2000.


Dosing Info:

Mylotarg is administered by intravenous infusion with or without chemotherapy.

Side Effects

Common adverse reactions include fever, nausea, vomiting, constipation, headache, rash, mouth sores, decreased appetite and elevated liver enzymes. Mylotarg can cause depletion of white blood cells (neutropenia) and platelets (thrombocytopenia), which can lead to infections and bleeding. Mylotarg should be administered with antihistamines or steroids to prevent infusion reactions. It can cause fetal harm if used during pregnancy.

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Last Reviewed: August 9, 2020