What is the new drug called Empliciti and how does it differ from other drugs used to treat multiple myeloma? —Name withheld on request

Elotuzumab (Empliciti) is an immunostimulatory monoclonal antibody recently approved by the FDA for the treatment of relapsed or refractory multiple myeloma. It is indicated for patients with multiple myeloma who have received 1 to 3 prior therapies.1

Elotuzumab is one of 3 drugs to be granted FDA approval for the treatment of relapsed/refractory multiple myeloma. The other 2 drugs are daratumumab (Darzalex), for patients who received at least 3 prior treatments, and ixazomib (Ninlaro), for patients with relapsed multiple myeloma who received at least 1 prior treatment.2

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Elotuzumab targets proteins on myeloma cells not yet targeted by other FDA-approved therapies for multiple myeloma. This unique feature is shared with daratumumab, also a monoclonal antibody.Side effects of Elotuzumab include increased heart rate, altered blood pressure, infection, or cataract.

Elotuzumab is not a single-agent therapy; it is indicated for use in combination with lenalidomide and dexamethasone. Its safety was tested in a randomized, open-label clinical study of 646 participants with relapsed or refractory disease. Study findings showed that progression-free survival was improved in patients taking elotuzumab with lenalidomide and dexamethasone compared with patients taking only lenalidomide and dexamethasone (19.4 months vs 14.9 months). In addition, 78.5% of patients taking the 3-drug combination experienced complete or partial shrinkage of their tumors compared with 65.5% of patients taking only lenalidomide and dexamethasone.1

The drug was granted breakthrough therapy designation for this indication. It was also granted priority review status and orphan drug designation.


1. FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma [FDA news release]. U.S. Food and Drug Administration Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474684.htm. Released November 30, 2015. Accessed March 1, 2016.

2. Three new therapies approved for multiple myeloma [news release]. National Cancer Institute Web site. http://www.cancer.gov/news-events/cancer-currents-blog/2016/fda-threedrugs-myeloma. Posted January 6, 2016. Accessed March 1, 2016.