Safety Alerts & Recalls

What does this mean?

Mylotarg will no longer be commercially available to new patients. If you are currently receiving the drug, you may complete your therapy following consultation with their healthcare professional. Your healthcare professionals should discuss with you the potential safety risks of Mylotarg.

If you are currently being treated with Mylotarg, please follow up with your doctor or other healthcare professional to review the benefits and risks of continuing Mylotarg and to discuss the other available treatments for you condition.

FDA: Pfizer Voluntarily Withdraws Mylotarg (gemtuzumab ozogamicin) From U.S. Market

Pfizer Inc. announced the voluntary withdrawal of the drug Mylotarg (gemtuzumab ozogamicin) from the U.S. market. The company took the action at the request of the U.S. Food and Drug Administration (FDA) after results from a recent clinical trial raised new concerns about the product's safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

Mylotarg (gemtuzumab ozogamicin), indicated for treatment of acute myeloid leukemia (AML), a bone marrow cancer, was approved in May 2000 under the FDA's accelerated approval program. A post approval clinical trial was begun by the manufacturer in 2004 to confirm effectiveness and safety of adding Mylotarg to standard chemotherapy in AML patients. The trial was stopped early when no improvement in survival time was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.

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Source: FDA
Publication Date: 2010-06-22
Last Updated: 2010-06-22

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