Mylotarg®
(gemtuzumab ozogamicin)
About Mylotarg
Mylotarg is a humanized monoclonal antibody-drug conjugate that links an antibody which binds to CD33 to cytotoxic antitumor antibiotic, known as calicheamicin. It is indicated for the treatment of patients with CD33+ acute myeloid leukemia (AML) in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. AML is a cancer of the myeloid line of white blood cells, characterized by the rapid proliferation of abnormal cells, which accumulate in the bone marrow and interfere with the production of normal blood cells. CD33 is a cell surface receptor that is often expressed on leukemic blast cells. AML is the most common acute leukemia affecting adults. Mylotarg was co-developed by Wyeth and UCB and marketed worldwide by Wyeth. Wyeth and Takeda have a joint venture agreement in Japan.
How Mylotarg Works
Mylotarg is linked to a cytotoxic and binds to CD33, an antigen which is found on the surface of leukemic cells in about 80% of patients. The antibody-drug conjugate allows for the targeted delivery of calicheamicin enhancing its killing ability of leukemia cells.
Current Indications
Mylotarg was launched in the US in May 2000 and in Japan in 2005 for the treatment of patients aged 60 and older in first relapse with CD33+ AML.
Clinical Trials
The EU MRC AML-15 and US SWOG S0106 trials are investigating the use of Mylotarg as first-line therapy in combination with chemotherapy for the treatment of AML.