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."
