Cedars-Sinai Medical Center

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A BI-WEEKLY PUBLICATION FROM THE CEDARS-SINAI CHIEF OF STAFF July 9, 2010 Issue | Archived Issues

Pharmacy Focus

Pfizer withdraws Mylotarg® from market

On June 21, Pfizer announced the voluntary withdrawal of the drug Mylotarg® (gemtuzumab ozogamicin) from the U.S market. 

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Imaging Case of the Month for July

A 68-year-old female with dyspnea on exertion underwent a CT coronary angiogram as part of her workup. 

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Meetings and Events

Interdisciplinary Diabetes Conference, July 13

Argentina: Land of Pampas, Gauchos, Tango, Polo and Soccer, July 20

Sand N' Snore, July 16

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Pharmacy Focus

Pfizer withdraws Mylotarg® from market

On June 21, Pfizer announced the voluntary withdrawal of the drug Mylotarg® (gemtuzumab ozogamicin) from the U.S market. It is used to treat patients with acute myeloid leukemia (AML). The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and failure to demonstrate clinical benefit to patients enrolled in trials.

As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.

Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.