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Pfizer Prepares for Voluntary Withdrawal of U.S. New Drug Application and for Discontinuation of Commercial Availability of Mylotarg®
Date:6/21/2010

ction toxicity rate was significantly higher in subjects given the combination of standard induction chemotherapy and Mylotarg than in those treated with chemotherapy alone.  After extensive discussions with the FDA, Pfizer has decided to withdraw the NDA effective October 15, 2010.

"We are disappointed that the study did not confirm the clinical benefit of Mylotarg.  Our primary concern is for patients who suffer from AML, which remains a very serious and difficult-to-treat disease with limited treatment options.  We advise patients to contact their physicians for further information," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer Oncology Business Unit.

Patients who are currently taking Mylotarg and those patients who have been prescribed Mylotarg may continue their course of therapy, in consultation with their physicians.  However, Pfizer recommends that no new patients in the U.S. be prescribed Mylotarg.  Future use of Mylotarg for new patients in the U.S. will require physician submission of an Investigational New Drug (IND) application to the FDA.  

The Company is also working with Health Authorities outside the U.S. and will keep patients, regulatory authorities, investigators and clinicians informed about FDA actions and appropriate next steps for Mylotarg.

For further information please contact Pfizer Medical Information at 1-800-438-1985 or at www.pfizer.com.

Mylotarg® (gemtuzumab ozogamicin for Injection) was approved in the U.S. as a single agent for patients with CD33
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SOURCE Pfizer Inc.
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