European Commission approves Empliciti + pomalidomide + low-dose dexamethasone to treat refractory multiple myeloma

Bristol-Myers Squibb Company announced that the European Commission (EC) has approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy.

This approval is based on data from the ELOQUENT-3 trial in which EPd doubled both median progression-free survival (PFS) and overall response rate (ORR) among patients with relapsed and refractory multiple myeloma versus pomalidomide and low-dose dexamethasone (Pd) alone. EPd is the first triplet combination approved in Europe based on a randomized clinical trial using the standard of care, Pd, as a comparator.

Results from ELOQUENT-3 demonstrated that the addition of Empliciti to Pd can significantly prolong survival without disease progression among heavily pretreated patients with multiple myeloma regardless of the number of prior therapies received.