Empliciti approved for multiple myeloma
(HealthDay)—Empliciti (elotuzumab), in combination with two other drugs, has been approved by the U.S. Food and Drug Administration to treat the blood cancer multiple myeloma. The drug is only approved for patients who have already been given one-to-three prior therapies for the disease.
Multiple myeloma is a type of cancer that affects germ-fighting white blood cells produced in bone marrow. Symptoms typically include a weakened immune system and bone and kidney problems. Nearly 27,000 new cases are projected in the United States, and more than 11,000 will die from it this year, the National Cancer Institute estimates.
Empliciti directs the immune system to kill multiple myeloma cells, the FDA explained Monday in a news release. It is approved in combination with another anti-cancer drug, Revlimid (lenalidomide), and the corticosteroid dexamethasone.
Empliciti was evaluated in clinical studies involving more than 640 people whose multiple myeloma returned or didn't respond to prior treatment. People who took the three-drug combination including Empliciti had an average disease-progression delay of 19.4 months, compared to about 15 months among those who took the other two drugs without Empliciti.
Empliciti's most common side effects included fatigue, diarrhea, fever, constipation, cough, nerve damage in the arms and legs, 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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