Bosutinib NDA Accepted for CML

February 2012, Vol 3, No 1 - FDA Approvals, News & Updates


The FDA has accepted a New Drug Application (NDA) for bosutinib (Pfizer), an oral dual Src and Abl tyrosine kinase inhibitor, as a second-line therapy for adult patients with previously treated Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML).

The submission was based on efficacy and safety data from a single-arm study of bosutinib in more than 500 patients with previously treated Ph+ CML, including those who were resistant or intolerant to imatinib or had previously received dasatinib or nilotinib. (January 27, 2012)