www.fdanews.com/articles/189180-fda-expands-approval-of-bristol-myers-squibbs-empliciti
FDA Expands Approval of Bristol-Myers Squibb’s Empliciti
November 14, 2018
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.