Bristol-Myers Gets Positive CHMP Opinion for Empliciti Combo

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 [e-mail]

(END) Dow Jones Newswires

July 26, 2019 07:41 ET (11:41 GMT)

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