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Pfizer Plans Regulatory Submissions of Bosutinib in Chronic Myeloid Leukemia
Date:12/3/2010

NEW YORK, Dec. 3, 2010 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) announced today it is planning regulatory submissions of bosutinib in patients with chronic myeloid leukemia (CML) based on data from a clinical program evaluating the compound in newly diagnosed and previously treated patients.  These regulatory submissions are planned for 2011.

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Pfizer has begun the process of preparing a Marketing Authorization Application (MAA) for submission to the European Medicine Agency (EMA) for bosutinib as a treatment option for patients with newly diagnosed Philadelphia chromosome positive (Ph+) CML.  The submission will be based on the results of the ongoing, Phase 3, randomized, open-label study of bosutinib versus imatinib in newly diagnosed patients with chronic phase Ph+ CML, called the BELA (Bosutinib Efficacy and safety in chronic myeloid LeukemiA) study.(1)

The Company has also had discussions with the United States (U.S.) Food and Drug Administration (FDA) regarding a possible regulatory submission for the use of bosutinib in the treatment of previously treated Ph+ CML patients. This submission would be based on the pending 24-month efficacy and safety data in the primary cohort of Study 200, which consists of more than 200 previously treated CML patients. Study 200 is a single arm study of bosutinib in over 500 patients with previously treated Ph+ CML, including patients resistant or intolerant to imatinib as well as patients who have become refractory to dasatinib or nilotinib.(2) Currently, there are no approved therapies available for CML patients who fail dasatinib or nilotinib in second line.(3,4,5)

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