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FDA Grants Priority Review to Elotuzumab (Empliciti) for Treatment of Multiple Myeloma

First review in U.S. for SLAMF7-directed immunostimulatory antibody

The FDA has accepted for priority review a biologics license application for elotuzumab (Empliciti, Bristol-Myers Squibb/AbbVie), 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.

Elotuzumab was previously granted a “breakthrough therapy” designation, which is intended to expedite the development and review of drugs for serious or life-threatening conditions.

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

The filing acceptance was primarily supported by data from the ELOQUENT-2 trial, a phase III, randomized, open-label study that evaluated elotuzumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone. The results of this trial were published in the New England Journal of Medicine.

In addition, the filing was supported by data from a phase II, randomized, open-label trial that evaluated elotuzumab with bortezomib and dexamethasone versus bortezomib and dexamethasone alone. The results from this study were presented at the 20th Congress of the European Hematology Association, held in June in Vienna, Austria.

Elotuzumab is an investigational immunostimulatory antibody targeted against SLAMF7, a cell-surface glycoprotein that is highly and uniformly expressed on myeloma cells and on natural killer cells, but is not detected on normal solid tissues or on hematopoietic stem cells. The safety and efficacy of elotuzumab have not been evaluated by the FDA or any other health authority.

Bristol-Myers Squibb and AbbVie are co-developing elotuzumab, with Squibb being solely responsible for commercial activities.

Despite advances in multiple myeloma treatment over the last decade, it remains a largely incurable disease, with only 45% of patients surviving 5 years after diagnosis. Many patients commonly experience a cycle of remission and relapse, in which they stop treatment for a short period but return to a treatment shortly afterwards. Following relapse, less than 20% of patients are alive after 5 years. Globally, more than 114,200 new cases of multiple myeloma are diagnosed each year, and more than 79,000 people die from the disease.

Source: Bristol-Myers Squibb; September 1, 2015.

 

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