FDA Approves Empliciti for Multiple Myeloma

Posted on December 7th, 2015 by

The United States Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for the treatment of patients with multiple myeloma who have received prior therapies.

The indication specifies that Empliciti is to be used in combination with lenalidomide and dexamethasone for the treatment of patients who have received one to three prior therapies for multiple myeloma.

Multiple myeloma is a type of blood cancer that affects certain immune cells called plasma cells. Healthy plasma cells produce proteins called antibodies that are an important part of the immune system’s defense for fighting bacteria and viruses.

Cancerous plasma cells tend to replicate at a fast pace, crowding out other healthy immune cells, as well as producing malfunctioning antibodies. These antibodies tend to cause damage to the kidneys, in addition to reducing the immune system’s ability to efficiently fight infection.

Empliciti is a monoclonal antibody that is targeted against the Signaling Lymphocyte Activation Molecule Family 7 (SLAMF7). Empliciti binds to SLAMF7, which is found on myeloma cells and results in the cells destruction through various processes, including stimulation of the immune system to fight the cancer cells.

The approval of Empliciti was based on a clinical trial that included 646 patients with multiple myeloma who had received one to three prior therapies for their disease. One group of patients was treated with Empliciti plus lenalidomide/dexamethasone, while the other group was treated with lenalidomide/dexamethasone only.

  • The median duration of progression-free survival (survival without progression of cancer) was 19.4 months for patients treated with Empliciti/lenalidomide/dexamethasone, compared with 14.9 months for those treated with lenalidomide/dexamethasone only.
  • Anti-cancer responses (partial or complete eradication of myeloma cells) occurred in 78.5% of patients treated with Empliciti combination, compared with 65.5% of patients treated with lenalidomide/dexamethasone.
  • The most common side effects that occurred more frequently among those treated with Empliciti included fatigue, diarrhea, fever, constipation and cough.

Reference: United States Food and Drug Administration (FDA). FDA news release. FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma. Accessed November 30, 2015. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474684.htm.

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Tags: dexamethasone, elotuzumab, Empliciti, fda, lenalidomide, Multiple Myeloma, News, Recurrent Multiple Myeloma, SLAMF7

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