- FDA Announcements
FDA Approved for RRMM: Elotuzumab (Empliciti) with lenalidomide and dexamethasone (Rd)
Updated: Nov 6, 2021
11/30/2015: Bristol-Myers Squibb and AbbVie Receive FDA Approval of Empliciti™ (elotuzumab) for the Treatment of Patients with Multiple Myeloma Who Have Received One to Three Prior Therapies.
Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for the treatment of multiple myeloma 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 randomized, open-label, Phase 3, ELOQUENT-2 study, which demonstrated that the ERd regimen resulted in a 30% reduction in the risk of disease progression or death compared to Rd alone (HR 0.70 [95% CI: 0.57, 0.85; p = 0.0004]).
11/30/2015: FDA Approval