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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

positive AML in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy.  Patients treated with Mylotarg receive one course of treatment that consists of two doses typically given 14 days apart.

AML is a relatively uncommon disease that affects approximately 13,000 new patients annually in the U.S.  It is estimated that less than 2,500 patients receive Mylotarg annually in the U.S.

SWOG S0106 Post Approval Study

With the agreement of FDA, a Phase 3 randomized, comparative controlled trial (SWOG S0106) using Mylotarg in combination with other chemotherapeutic agents (daunorubicin and cytosine arabinoside) versus chemotherapy alone in first-line AML patients under the age of 61 was conducted to confirm clinical benefit for Mylotarg.  A total of 627 patients were enrolled in this study.  Although SWOG S0106 did not confirm the clinical benefit, the results do not directly impact the risk/benefit profile of Mylotarg in its approved indication as a single agent.

Additionally, among all patients evaluable for early toxicity, the fatal induction toxicity rate was significantly higher in the daunorubicin and cytosine arabinoside + Mylotarg arm compared to the daunorubicin and cytosine arabinoside arm (16/283=5.7% vs. 4/281=1.4%, P=0.01).

About Mylotarg® (gemtuzumab ozogamicin for Injection)

Important safety information:

Mylotarg should be administered under the supervision of physicians experienced in the treatment of acute leukemia and in facilities equipped to monitor and treat leukemia patients.

There are no controlled trials demonstrating efficacy and safety using Mylotarg in combination with other chemother
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SOURCE Pfizer Inc.
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