Pfizer files bosutinib at FDA for PH+CML

The FDA has accepted its New Drug Application (NDA) for standard review of bosutinib, a once a day oral dual Src and Abl kinase inhibitor from Pfizer, 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. see Study 200- ASH Accepted Abstract #892. Bosutinib as Third-Line Treatment for Chronic Phase Chronic Myeloid Leukemia Following Failure of Second-Line Therapy with Dasatinib or Nilotinib. Oral Presentation. H. J. Khoury - Presenter. 52nd American Society of Hematology Annual Meeting. Orlando, FL. December 4-7, 2010