Bristol-Myers Squibb and AbbVie have announced that their co-development project for an antibody therapy against Multiple Myeloma has been approved in the EU after a successful Phase III trial.
Empliciti (elotuzumab) has been developed for the treatment of multiple myeloma as combination therapy in patients who have received at least one prior therapy, now making it the first and only immunostimulatory antibody approved for multiple myeloma in the EU.
The approval is based on data from the Phase III ELOQUENT-2 study, which evaluated Empliciti in combination with the thalidomide dervivate lenalidomide and the steroid dexamethasone. The trial ran for 646 patients in total across Europe as well as Australia, Japan and Russia.
Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.