FDA approves new Bristol-Myers treatment for multiple myeloma
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(Reuters)
The U.S. Food and Drug Administration said on Monday it had approved a drug to be sold by Bristol-Myers Squibb Co as a treatment for a form of blood cancer.
The FDA said it approved the treatment, Empliciti, to be used in multiple myeloma patients in combination with Celgene Corp's Revlimid and common anti-inflammatory drug dexamethasone.
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.
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Research has shown that combination treatments increase the time that multiple myeloma patients survive without the disease.
The FDA said that Empliciti is the second immuno-oncology treatment for multiple myeloma to be approved, after Johnson & Johnson's Darzalex.
Bristol-Myers and AbbVie Inc co-developed the drug, but Empliciti will be sold only by Bristol-Myers.
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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.
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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Bristol-Myers shares were down about 1 percent at $67.22 on Monday morning on the New York Stock Exchange.