Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration, or FDA, has accepted its New Drug Application, or NDA, for standard review of bosutinib as a treatment option for adult patients with previously treated Philadelphia chromosome positive, or Ph+, chronic myeloid leukemia, or CML.
The company noted that the NDA 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.
For comments and feedback: editorial@rttnews.com