Bristol-Myers Squibb and AbbVie’s experimental multiple myeloma drug Empliciti has been cleared for US use just three months after regulators said they would undertake a priority review of the drug.
Empliciti (elotuzumab) is an immuno-stimulatory antibody targeting 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 ‘breakthrough’ drug has been approved by the US Food and Drug Administration in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone in patients who have received one to three prior therapies, offering access to a monoclonal antibody shown in trials to extend progression-free survival.
Approval was based on data from the 646-patient ELOQUENT-2 trial, in which patients taking Empliciti plus Revlimid/dexamethasone experienced a significant delay in the amount of time before their disease worsened (19.4 months) compared to those taking only Revlimid/dexamethasone (14.9 months).
Also, 78.5 percent of those taking the Empliciti-based regimen saw a complete or partial shrinkage of their tumours compared to 65.5 percent in those only taking Revlimid/dexamethasone alone.
The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the US this year. Johnson & Johnson’s Darzalex (daratumumab), which won US clearance earlier this month, is the only other FDA-approved monoclonal antibody for the treatment of the disease.