Bristol-Myers Squibb and AbbVie announced that the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies. BMS has proposed the name Empliciti which, if approved, will serve as the brand name for elotuzumab.
The filing acceptance is primarily supported by data from the ELOQUENT-2 trial, a Phase 3, randomized, open-label study, which 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, the filing was supported by data from study CA204-009, a Phase 2, randomized, open-label study which evaluated Empliciti with bortezomib and dexamethasone versus bortezomib and dexamethasone alone.
Elotuzumab is an investigational immunostimulatory antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7), a cell-surface glycoprotein that is highly and uniformly expressed on myeloma cells and Natural Killer (NK) cells, but is not detected on normal solid tissues or on hematopoietic stem cells.
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