FDA Approves New Blood-Cancer Drug Empliciti -- Update
November 30 2015 - 12:12PM
Dow Jones News
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.
The monthly cost of Empliciti for biweekly doses is
approximately $10,000. On average, the first-year costs, including
special induction cycles, is approximately $142,000.
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 austen.hufford@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
November 30, 2015 11:57 ET (16:57 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
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