FDA approves Empliciti for the treatment of multiple myeloma

Bristol-Myers Squibb and AbbVie have announced that Empliciti (elotuzumab) has been approved by the US Food and Drug Administration (FDA) for the treatment of multiple myeloma.

Empliciti has been approved as combination therapy with Revlimid (lenalidomide) and dexamethasone (ERd) in patients who have received one to three prior therapies.

The approval of this first and only immunostimulatory antibody for multiple myeloma is based on data from the Phase 3 ELOQUENT-2 study. Those taking Empliciti plus Revlimid and dexamethasone experienced a delay in the amount of time before their disease worsened (19.4 months) compared to participants taking only Revlimid and dexamethasone (14.9 months). Additionally, 78.5% of those taking Empliciti with Revlimid and dexamethasone saw a complete or partial shrinkage of their tumours compared to 65.5% in those only taking Revlimid and dexamethasone.

Empliciti represents ‘a fundamentally different approach’

“With today’s approval of Empliciti, we are pleased to now bring the promise of our Immuno-Oncology research to patients with multiple myeloma,” said Francis Cuss, MB Bchir, FRCP, chief scientific officer, Bristol-Myers Squibb. “Empliciti represents a fundamentally different approach of directly activating the immune system in patients with relapsed or refractory multiple myeloma, delivering improved outcomes for those in need.”

Empliciti specifically targets Signalling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer cells, plasma cells, and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

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.

The treatment is available for injection for intravenous use in 300 mg and 400 mg vials. Bristol-Myers Squibb expects to begin shipping the treatment within the next 48 hours. Empliciti is also under review by the European Medicines Agency and has been granted accelerated assessment.

“Multiple myeloma remains largely incurable, with only half of patients surviving five years after diagnosis,” said Sagar Lonial, M.D., chief medical officer of the Winship Cancer Institute of Emory University. “The approval of elotuzumab provides renewed hope for the multiple myeloma community who urgently need a treatment option that extends the time patients live without their disease progressing.”