New Immunotherapy Combination Granted FDA Approval for Certain Adults with Multiple Myeloma – APhA submits compounding comments to FDA. – (866) 348-2889.
Officials with the FDA have approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of certain patients with relapsed or refractory multiple myeloma, according to a press release.1
EPd is the first triplet combination to be approved based on a randomized clinical trial using Pd as a comparator, according to Bristol-Myers Squibb.1
The approval is indicated for adult patients with multiple myeloma who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor. The approval is based on data from the ELOQUENT-3 phase 2 trial, which evaluated elotuzumab plus pomalidomide and dexamethasone (Pd) versus Pd in 117 patients with relapsed or refractory multiple myeloma. According to the results, EPd doubled both median progression-free survival (PFS) and overall response rate (ORR) versus Pd.1