FDA Approves Additional Multiple Myeloma Indication for Empliciti
Empliciti is a SLAMF7-directed immunostimulatory antibody
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) injection for use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adults with multiple myeloma who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor.
Approval was based on results from ELOQUENT-3, a Phase 2, open-label trial (N=117) involving patients with relapsed or refractory multiple myeloma. Patients were randomized to receiver either EPd or pomalidomide and low-dose dexamethasone (Pd). Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity. Treatment with EPd reduced the risk of disease progression by 46% (hazard ratio [HR] 0.54, 95% CI, 0.34 to 0.86; P =.0078). Specifically, median progression-free survival (PFS) was 10.25 months in the EPd group and 4.67 months in the Pd group after a minimum follow-up of 9.1 months.
Overall response rate (ORR) doubled in patients who received EPd vs Pd (53.3% vs 26.3%; P =.0029). Very good partial responses or better were seen in 20% of EPd patients vs 8.8% of Pd patients.
Empliciti, a SLAMF7-directed immunostimulatory antibody, is also approved in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received 1–3 prior therapies.
It is supplied as 300mg and 400mg per vial lyophilized powder for intravenous (IV) infusion after reconstitution.
For more information call (800) 321-1335 or visit Empliciti.com.