Pfizer: FDA grants priority review to leukemia drug.
(CercleFinance.com) - Pfizer said that a supplemental new drug application for Bosulif has been accepted and granted priority review by the FDA in the US.
If approved, the filing would expand the approved use of Bosulif to include patients who have newly diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).
Bosulif is currently indicated in the US for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy.
As a reminder, priority review status accelerates FDA review time from 10 months to a target of six months
In addition, the European Medicines Agency (EMA) has validated for review a variation application for use of Bosulif in the same patient population.
opyright (c) 2017 CercleFinance.com. Tous droits réservés.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
If approved, the filing would expand the approved use of Bosulif to include patients who have newly diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).
Bosulif is currently indicated in the US for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy.
As a reminder, priority review status accelerates FDA review time from 10 months to a target of six months
In addition, the European Medicines Agency (EMA) has validated for review a variation application for use of Bosulif in the same patient population.
opyright (c) 2017 CercleFinance.com. Tous droits réservés.
Copyright (c) 2017 CercleFinance.com. All rights reserved.