FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma


Get Permission

Bristol-Myers Squibb and AbbVie recently announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for elotuzumab, an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies.

Elotuzumab was previously granted Breakthrough Therapy designation, which is intended to expedite the development and review of drugs for serious or life-threatening conditions.

The filing acceptance is primarily supported by data from the phase III ELOQUENT-2 trial, a randomized, open-label study, which evaluated elotuzumab in combination with lenalidomide (Revlimid) and dexamethasone vs lenalidomide and dexamethasone alone. The results of this trial were reported by Lonial et al in The New England Journal of Medicine.

Additionally, the filing was supported by data from study CA204-009, a phase II, randomized, open-label study that evaluated elotuzumab with bortezomib (Velcade) and dexamethasone vs bortezomib and dexamethasone alone. These phase II results were presented in an oral session at the 20th Congress of the European Hematology Association. ■



Advertisement

Advertisement



Advertisement