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Dr. Siegel on the Carfilzomib FDA Approval Process

David S. Siegel, MD, PhD
Published: Monday, Mar 14, 2011

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.

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.


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