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FDA Approves Empliciti for Multiple Myeloma

Monoclonal antibody works with another approved therapy to provide additional benefit

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MONDAY, Nov. 30, 2015 (HealthDay News) -- Empliciti (elotuzumab), in combination with two other drugs, has been approved by the U.S. Food and Drug Administration to treat multiple myeloma. The drug is only approved for patients who have already been given one to three prior therapies for the disease.

Empliciti, a monoclonal antibody, activates the body's immune system to attack and kill multiple myeloma cells, the FDA explained Monday in a news release. It is approved in combination with another FDA-approved treatment for multiple myeloma, Revlimid (lenalidomide), and the corticosteroid dexamethasone.

Empliciti was evaluated in clinical studies involving 646 people whose multiple myeloma returned or didn't respond to prior treatment. Patients who took the three-drug combination including Empliciti had an average disease-progression delay of 19.4 months, compared to 14.9 months among those who took the other two drugs without Empliciti.

Empliciti's most common side effects included fatigue, diarrhea, fever, constipation, cough, peripheral neuropathy, nasal infection, respiratory infection, loss of appetite, and pneumonia.

The drug is marketed by New York City-based Bristol-Myers Squibb.

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