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FDA Approves New Bristol-Myers Treatment for Multiple Myeloma

November 30, 2015

By Reuters Staff

The U.S. Food and Drug Administration has approved elotuzumab (Empliciti, Bristol-Myers Squibb) in combination with Revlimid (lenalidomide) and dexamethasone to treat people with multiple myeloma who have received one to three prior medications.

The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States in 2015.

"We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

"Today's approval is the second monoclonal antibody approved to treat patients with multiple myeloma and works with another approved therapy to provide additional benefit." Darzalex (daratumumab), approved earlier this month, is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma.

Research has shown that combination treatments increase the time that multiple myeloma patients survive without the disease.

Bristol-Myers and AbbVie Inc co-developed the drug, but Empliciti will be sold only by Bristol-Myers.

The company is considered the leader among drugmakers racing to develop a new wave of cancer treatments that harness the immune system, including its recently approved immuno-oncology product Opdivo (nivolumab).

Opdivo was approved in December for advanced melanoma and was approved in March to treat the less-common squamous type of non-small cell lung cancer.

Sales of Opdivo reached $305 million the latest quarter, putting it on track to become a blockbuster product.


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