Bristol-Myers Squibb and AbbVie’s experimental multiple myeloma drug elotuzumab has taken a huge leap towards US approval after regulators said they would undertake a speedy six-month review of its marketing application.
The companies are seeking to market the drug, under the proposed brand name Empliciti, for treatment of the blood cancer as combination therapy in patients who have received one or more prior treatments.
Elotuzumab is an investigational immuno-stimulatory antibody targeted against SLAMF7, a cell-surface glycoprotein that is highly and uniformly expressed on myeloma cells and Natural Killer cells, but not on normal solid tissues or on haematopoietic stem cells.
The filing is based in part on early data from the 646-patient ELOQUENT-2 trial, which showed that adding elotuzumab to therapy with Revlimid (lenalidomide) and dexamethasone cut the risk of disease progression by 30% and extended remission by 4.5 months.
Results taken at two-year follow-up showed that PFS in patients given the elotuzumab-based therapy regimen was 19.4 months compared to 14.9 months in the control arm, while one-year PFS was 68% versus 57%, and two-year PFS 41% vs 27%, respectively.
Elotuzumab has been awarded ‘breakthrough’ status in the US, which is designed to accelerate development and review of therapies for serious or life-threatening conditions.