FDA Approves New Blood-Cancer Drug Empliciti

By Austen Hufford 

The Food and Drug Administration said Monday that it approved Bristol-Myers Squibb Co.'s Empliciti to treat multiple myeloma, a form of blood cancer. The FDA approved Empliciti to be used in combination with two other FDA-approved treatments, Janssen Biotech's Darzalex and Celgene Corp.'s Revlimid.

In a 646-participant clinical trial, those treated with the three-drug cocktail took longer to relapse and had a higher chance of tumor shrinkage than those treated with the two-drug therapy.

Multiple myeloma is a type of blood cancer that occurs in infection-fighting white blood cells found in the bone marrow. The National Cancer Institute estimates there will be 26,850 new multiple myeloma cases and 11,240 related deaths in the U.S. this year. Empliciti activates the body's own immune system to attack and destroy multiple myeloma cells.

Bristol-Myers and AbbVie Inc. are codeveloping the drug, with Bristol-Myers responsible for marketing and commercial activities.

Earlier this month, Darzalex was also approved to treat the disease. Special designations from the FDA for both Empliciti and Darzalex allowed them to go through the review process faster than normal. The FDA granted the drugs breakthrough therapy designations, priority reviews and orphan-drug designations.

Write to Austen Hufford at [e-mail]

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(END) Dow Jones Newswires

November 30, 2015 11:53 ET (16:53 GMT)

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