Printer Friendly

FDA accepts BLA for Pfizer leukemia drug.

The Food and Drug Administration has accepted a Biologies License Application (BLA) from Pfizer Inc. for inotuzumab ozogamicin and granted it priority review. The drug is being evaluated for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. In October 2015 the agency granted inotuzumab ozogamicin a Breakthrough Therapy designation, which accelerates FDA review time from 10 months to a goal of six months from the day the fihng is accepted. It is given to drugs that might offer major treatment advances or provide a treatment for which no adequate therapy exists. Pfizer has also submitted a Marketing Authorization Application for the drug to the European Medicines Agency, which is reviewing it.

COPYRIGHT 2017 Racher Press, Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2017 Gale, Cengage Learning. All rights reserved.

 
Article Details
Printer friendly Cite/link Email Feedback
Title Annotation:Rx Update
Publication:Chain Drug Review
Date:Mar 13, 2017
Words:115
Previous Article:Trump blasts FDA approval process.
Next Article:Grassley considers Orphan Drug Act inquiry.
Topics:

Terms of use | Privacy policy | Copyright © 2018 Farlex, Inc. | Feedback | For webmasters