Bristol-Myers Squibb Co. said 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.
Richard Pazdur, founding director of FDA’s Oncology Center of Excellence and long-time FDA visionary, has accepted the top job at FDA’s Center for Drug Evaluation and Research following George F. Tidmarsh’s dramatic ouster from the position.
