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New FDA Approval for Pfizer's MYLOTARG™ (gemtuzumab ozogamicin)

On September 1, 2017,  Pfizer announced that the U.S. Food and Drug Administration approved MYLOTARG™ (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.1 MYLOTARG is the first therapy with an indication that includes pediatric AML. It is also the only AML therapy that targets CD33, an antigen expressed on AML cells in up to 90% of patients. approval of MYLOTARG® (gemtuzumab ozogamicin) Injection for IV infusion. The following information is for State Society review:

Click Here to read the press release.

Click Here for prescribing information.