Bristol-Myers Squibb and AbbVie announced that the Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) injection for the treatment of multiple myeloma as combination therapy with Revlimid (lenalidomide; Celgene) and dexamethasone in patients who have received 1–3 prior therapies. Empliciti is the first immunostimulatory antibody approved for multiple myeloma.

The FDA approval was based on data from the Phase 3 randomized, open-label study (ELOQUENT-2) that enrolled 646 patients who had received 1–3 prior therapies. The co-primary endpoints were progression-free survival (PFS) and overall response rate (ORR). Study results showed that Empliciti in combination with Revlimid and dexamethasone led to a 30% reduction in the risk of disease progression or death compared to Revlimid and dexamethasone alone (HR 0.70, 95% CI: 0.57, 0.85; P=0.0004). In addition, the PFS rates in the Empliciti arm compared to the Revlimid arm was 68% vs. 5% at 1 year, and 41% vs. 27% at 2 years, respectively. 

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Empliciti works by specifically targeting Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. It directly activates the immune system through natural killer cells via the SLAMF7 pathway and targets SLAMF7 on myeloma cells, tagging them for cell-mediated destruction through antibody-dependent cellular toxicity.

Empliciti is available as an injection for intravenous use in 300mg and 400mg strength single-dose vials. It is expected to launch in the next two days. 

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