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