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Empliciti (elotuzumab) to get priority review by FDA

by Beacon Staff on Tue Sep 01, 2015 10:29 am

Bristol-Myers Squibb announced this morning that the U.S. Food and Drug Administration has granted priority review to the application to have Empliciti (elotuzumab) approved as a new treatment for multiple myeloma.

The full press release with the news can be viewed here at The Beacon at this link:

https://myelomabeacon.org/pr/2015/09/01/empliciti-elotuzumab-fda-priority-review/

Here's the first paragraph of the press release:

"Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for Empliciti (elotuzumab), an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of mul­ti­ple myeloma as com­bi­nation therapy in patients who have received one or more prior ther­a­pies. Empliciti was previously granted Break­through Therapy Designation, which according to the FDA, is intended to expedite the development and review of drugs for serious or life-threatening conditions. The European Medicines Agency (EMA) also recently validated for re­view the Marketing Authorization Application for Empliciti, granting it accelerated assess­ment."

Beacon Staff

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