Pfizer (PFE) NDA for Bosutinib Standard Review Accepted by FDA
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Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for standard review of bosutinib as a treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). This submission was based on efficacy and safety data from Study 200, 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 were previously treated with dasatinib or nilotinib. Currently, there are no approved therapies available for CML patients after second-line treatment with dasatinib or nilotinib.
CML, one of the four main types of leukemia,1 accounts for 15 percent of all leukemias worldwide.2 Despite the availability of existing treatments, there remains a need for additional options for CML patients, given observed treatment–related toxicities and resistance.
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CML, one of the four main types of leukemia,1 accounts for 15 percent of all leukemias worldwide.2 Despite the availability of existing treatments, there remains a need for additional options for CML patients, given observed treatment–related toxicities and resistance.
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