EMA validates filing of Empliciti + pomalidomide + low-dose dexamethasone to treat multiple myeloma. BMS
Bristol-Myers Squibb Company announced that the European Medicines Agency (EMA) has validated the Company�s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with 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.
Validation of the application confirms the submission is complete and begins the EMA�s centralized review process. The application is based on data from ELOQUENT-3, a randomized Phase II study evaluating the EPd combination versus pomalidomide and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM). Data from this study were presented at the 23rd Congress of the European Hematology Association in June 2018.
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