EMA validates for review Empliciti (elotuzumab) to treat multiple myeloma- BMS

BMS and AbbVie have announced the European Medicines Agency (EMA) validated for review the Marketing Authorization Application (MAA) for Empliciti (elotuzumab), an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in adult patients who have received one or more prior therapies. The application was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The MAA is primarily supported by data from two randomized clinical trials, each combining Empliciti with a different standard of care regimen for multiple myeloma. ELOQUENT-2, a Phase III, randomized, open-label study, evaluated Empliciti in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone. The results of this trial were published in The New England Journal of Medicine on June 2. Additionally, a Phase II, randomized, open-label study (Study CA004-009) evaluated Empliciti with bortezomib and dexamethasone versus bortezomib and dexamethasone alone. These Phase II results were presented in an oral session (Abstract #S103) at the 20th Congress of the European Hematology Association (EHA).

Comment: Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.