Posted by Michael Wonder on 23 Aug 2018
U.S. FDA accepts for priority review BMS’ application for Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone in patients with relapsed or refractory multiple myeloma
23 August 2018 - Application based on results from Phase 2 ELOQUENT-3 study.
Bristol-Myers Squibb today announced that the U.S. FDA accepted its supplemental biologics license application for Empliciti (elotuzumab) in combination with pomalidomide and low dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
The FDA granted the application priority review with an action date of 27 December 2018.
