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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.

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Title Annotation:Rx Update
Publication:Chain Drug Review
Date:Mar 13, 2017
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