Bristol-Myers Gets Positive CHMP Opinion for Empliciti Combo
July 26 2019 - 7:56AM
Dow Jones News
By Colin Kellaher
Bristol-Myers Squibb Co. (BMY) on Friday said the European
Medicines Agency's Committee for Medicinal Products for Human Use
recommended marketing authorization of a combination based on
Empliciti in a form of multiple myeloma.
The New York biopharmaceutical company said the CHMP positive
opinion covers the use of Empliciti plus pomalidomide and low-dose
dexamethasone for adults with relapsed and refractory multiple
myeloma who have received at least two prior therapies, including
lenalidomide and a proteasome inhibitor, and have demonstrated
disease progression on the last therapy.
The European Commission, which generally follows the CHMP's
recommendations, will now review the opinion.
The U.S. Food and Drug Administration in November approved the
combination for adults with multiple myeloma who have received at
least two prior therapies.
Multiple myeloma is a cancer that forms in a type of white blood
cells called plasma cells and causes cancer cells to accumulate in
the bone marrow.
Bristol-Myers, which is co-developing Empliciti with AbbVie Inc.
(ABBV), has sole responsibility for commercial activities.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 26, 2019 07:41 ET (11:41 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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