Posted by Michael Wonder on 29 Aug 2017
U.S. FDA and EMA accept regulatory submissions for Bosulif (bosutinib) for the treatment of patients with newly diagnose Ph+ chronic myeloid leukaemia
29 August 2017 - Applications seek to expand approved use of Bosulif into first- line treatment based on positive results from Phase 3 head-to-head trial.
Pfizer and Avillion today announced that a supplemental New Drug Application (sNDA) for BOSULIF® (bosutinib) has been accepted for filing and granted Priority Review by the U.S. FDA. If approved, the sNDA would expand the approved use of Bosulif to include patients with newly diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Bosulif is currently indicated in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy.
Priority review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing, and is given to drugs that may offer major advances in treatment or may provide a treatment for which no adequate therapy exists. The Prescription Drug User Fee Act goal date for a decision by the FDA is in December 2017.
