EU approves Empliciti (elotuzumab) for multiple myeloma- BMS/AbbVie

Bristol-Myers Squibb and AbbVie have announced that the European Commission has approved Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy with Revlimid (lenalidomide) and dexamethasone in patients who have received at least one prior therapy. Empliciti is now the first and only immunostimulatory antibody approved for multiple myeloma in the European Union (EU).

The approval is based on data from the randomized, open-label, Phase III ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone. The co-primary endpoints of this study, progression-free survival (PFS) as assessed by hazard ratio (HR) and overall response rate (ORR), were achieved, with extended follow-up data showing a 53% relative improvement in PFS rate at three years (23% versus 15%). Additionally, a pre-specified interim analysis for overall survival (OS) found a positive trend favoring the Empliciti combination versus Rd alone, though at the time of the interim analysis, the OS endpoint had not reached the pre-determined threshold for statistical significance. Patients will continue to be followed for survival, and the final analysis is pending.

Comment: Darzalex (daratumumab) from Janssen Biotech, approved in January 2016, is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma. Other recently approved drugs for multiple myeloma are Pomalyst (pomalidomide) from Celgene and Darzalex (daratumumab) from Janssen Biotech.The potential market leader may be Kyprolis (carfilzomib) from Amgen.