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news.Pfizer is planning for regulatory submissions of Bosutinib in patients with chronic myeloid leukemia (CML) in 2011 based on data from a clinical program evaluating the compound in newly diagnosed and previously treated patients.
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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, randomised, 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.
Pfizer Oncology business unit president and general manager Garry Nicholson said their ongoing analysis of the Bosutinib clinical development program reinforces their belief that Bosutinib may provide benefit for patients living with CML, and they are working closely with health authorities and other experts toward their goal of making this promising compound available to patients who need it.