Pfizer (PFE) and the private Avillion reported Tuesday a supplemental new drug application for bosutinib, a drug to treat certain types of myeloid leukemia, has been accepted for filing and granted priority review by the U.S. Food and Drug Administration (FDA).
Pfizer said that if approved, the new application would expand the approved use of bosutinib to include patients with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myeloid leukemia.
Pfizer noted bosutinib is currently indicated in the U.S. for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia, 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.
Pfizer reported that in addition, the European Medicines Agency has validated for review a Type II Variation application for use of bosutinib in the same patient population.
Pfizer said the new submissions are based on results a phase 3 study which showed bosutinib was associated with a significantly higher rate of patients achieving major molecular response at 12 months (the primary endpoint) compared to the rate achieved in patients treated with imatinib.
Pfizer and Avillion entered into an exclusive collaborative development agreement in 2014 to test bosutinib. Under the terms of the agreement, Avillion provided funding and conducted the trial to generate the clinical data used to support these applications and other potential regulatory filings for marketing authorization for bosutinib as first-line treatment for patients with certain types of myeloid leukemia.
Pfizer said that if bosutinib is approved for this indication, Avillion will be eligible to receive milestone payments from Pfizer, and that Pfizer retains all rights to commercialize bosutinib globally.