FDA and EMA accept supplemental New Drug Application for Bosulif (bosutinib) in newly diagnosed chronic phase Ph+ chronic myeloid leukemia.-Pfizer and Avillion.

Pfizer and Avillion announced that a supplemental New Drug Application 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). The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in December 2017.

In addition, the European Medicines Agency (EMA) has validated for review a Type II Variation application for use of Bosulif in the same patient population. In Europe, Bosulif has conditional marketing authorization for the treatment of adult patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

The submissions are based on results from BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment), a multi-center, multinational, open-label Phase III study which showed Bosulif 400 mg was associated with a significantly higher rate of patients achieving major molecular response (MMR) at 12 months (the primary endpoint) compared to the rate achieved in patients treated with imatinib. Results from the trial were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in May 2017 and at the European Hematology Association (EHA) Meeting in June 2017. The adverse events seen in the trial were consistent with the known safety profile for Bosulif . The proposed dosing for the newly diagnosed patients is 400 mg daily, which is different from the currently approved dosing in patients who are resistant or intolerant to prior TKI therapy (500 mg daily).