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Dr. David Siegel from John Theurer Cancer Center on the Carfilzomib FDA Approval Process
David S. Siegel, MD, PhD, Chief, Multiple Myeloma at John Theurer, discusses the process of receiving FDA approval for carfilzomib (Kyprolis), a proteasome inhibitor that is highly active against multiple myeloma cells.
Siegel feels the Phase II information will be enough to gain approval for the drug. The phase III ASPIRE trial is already underway that is required for the FDA rapid approval.
The FDA approved carfilzomib (Kyprolis) for patients with multiple myeloma who received at least two prior lines of therapy, on July 20, 2012.