U.S. Food and Drug Administration accepts for priority review the biologics license application for Empliciti (elotuzumab) for the treatment of multiple myeloma in patients who have received one or more prior therapies

FDA

1 September 2015 - Bristol-Myers Squibb Company and AbbVie 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.

Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health authorities, will serve as the brand name for elotuzumab.

For more details, go to: http://news.bms.com/press-release/us-food-and-drug-administration-accepts-priority-review-biologics-license-application-

Michael Wonder

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Michael Wonder

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Cancer , US , Submission , Priority review