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FDA to give blood cancer drug faster review

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The Associated Press | May 19, 2014 09:58 AM EST | AP


A potential blood cancer treatment from drugmakers AbbVie and Bristol-Myers Squibb has been named a "breakthrough therapy" by the Food and Drug Administration, a designation designed to speed up the drug's testing and approval process.

The companies said Monday the drug, elotuzumab, received the designation for use in combination with another treatment, lenalidomide, and the steroid dexamethasone for treating multiple myeloma patients who have already tried other therapies. The designation was based on findings from a midstage study of that treatment combination.

Researchers also are studying elotuzumab in late-stage trials, which are the final phase of research before drug developers submit their treatment to regulators for approval.

Multiple myeloma, which starts in bone marrow, is the second most common form of blood cancer. It has a five-year survival rate of nearly 45 percent. Elotuzumab aims to fight the disease by binding to a protein present in cancerous cells but not detectable in normal, healthy ones. Researchers are trying to determine if the drug, after binding to the cancer cell, prompts the patient's immune system to kill it.

New York-based Bristol-Myers Squibb Co. and North Chicago, Illinois-based AbbVie Inc., which was spun off last year from Abbott Laboratories, are co-developing the drug.

Shares of Bristol-Myers climbed 6 cents to $48.84 shortly after trading started Monday, while AbbVie rose 30 cents to $53.23, and the Standard & Poor's 500 index started off nearly flat.