Empliciti given priority review at FDA for treatment of multiple myeloma- BMS

BMS and AbbVie announced the FDA has accepted for priority review the Biologics License Application (BLA) for Empliciti (elotuzumab), an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies.

The filing acceptance is primarily supported by data from the ELOQUENT-2 trial, a Phase III, randomized, open-label study, which evaluated elotuzumab in combination with lenalidomide (Revlimid) and dexamethasone versus lenalidomide and dexamethasone alone. The results of this trial were published in The New England Journal of Medicine on 2 June. Additionally, the filing was supported by data from study CA204-009, a Phase II, randomized, open-label study which evaluated elotuzumab with bortezomib (Velcade) 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).

Empliciti was previously granted Breakthrough Therapy Designation, which according to the FDA, is intended to expedite the development and review of drugs for serious or life-threatening conditions. The European Medicines Agency (EMA) also recently validated for review the Marketing Authorization Application for Empliciti, granting it accelerated assessment.

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