On December 19, 2017, 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).

Pfizer Press Release:

https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_bosulif_bosutinib_for_the_treatment_of_patients_with_newly_diagnosed_ph_chronic_myelogenous_leukemia_cml

Prescribing information:

http://labeling.pfizer.com/ShowLabeling.aspx?id=884