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Pfizer (PFE) Granted FDA Approves BOSULIF (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia
December 19, 2017 4:17 PM ESTPfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for BOSULIF® (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The sNDA was reviewed and approved under the FDAs Priority Review and accelerated approval programs based on molecular and cytogenetic response rates. Continued approval for this indication may be contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow up trial. BOSULIF was first approved... More
