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News From the Food and Drug Administration
October 17, 2017

Leukemia Drug Makes a Comeback

JAMA. 2017;318(15):1432. doi:10.1001/jama.2017.14917

Seven years after it was withdrawn from the market because of safety and efficacy issues, gemtuzumab ozogamicin has received approval for certain children and adults with acute myeloid leukemia.

Marketed as Mylotarg, the drug is now indicated for adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen (CD33-positive AML). Approval also was granted to treat pediatric patients aged 2 years or older with CD33-positive AML who have relapsed or haven’t responded to initial therapy. The CD33 antigen is expressed on AML cells in up to 90% of patients, according to a statement from the manufacturer, Pfizer Inc. Gemtuzumab ozogamicin consists of an antibody that binds with the CD33 antigen and kills cancer cells by releasing the antitumor agent calicheamicin into them.

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