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Pharmaceuticals / Submissions and Approvals

FDA Expands Approval of Bristol-Myers Squibb’s Empliciti

Nov. 15, 2018
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Bristol-Myers Squibb announced that the FDA has granted its multiple myeloma treatment Empliciti (elotuzumab) expanded approval.

The treatment is now approved for intravenous use as a combination therapy with pomalidomide and dexamethasone (EPd) for treating multiple myeloma in adult patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

EPd is the first triplet combination approved based on a randomized clinical trial using pomalidomide and dexamethasone as comparators.

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