Posted on March 5th, 2010 by
The U.S. Food and Drug Administration (FDA) has approved expanded prescribing information for Velcade® (bortezomib). Velcade’s label now includes results from the VISTA study, which show that Velcade improves long-term overall survival among patients with previously untreated multiple myeloma.
Multiple myeloma is a cancer of plasma cells. Plasma cells are a special type of white blood cell that are part of the body’s immune system. Plasma cells normally live in the bone marrow and make proteins, called antibodies, which circulate in the blood and help fight certain types of infections. Plasma cells also play a role in the maintenance of bone by secretion of a hormone called osteoclast activating factor, which causes the breakdown of bone. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine. These abnormal antibodies are referred to as paraproteins or monoclonal proteins in the blood (M proteins) or urine (Bence Jones protein).
Velcade is the first in a new class of anticancer agents known as proteasome inhibitors. It’s been shown to provide benefits in the treatment of multiple myeloma and mantle cell lymphoma.
The VISTA study is an international Phase III clinical trial. The study enrolled 682 newly diagnosed multiple myeloma patients who were ineligible for stem cell transplantation. Patients were assigned to receive treatment with melphalan and prednisone (MP) alone or in combination with Velcade. Patients have now been followed for a median of 36.7 months.
Compared with patients treated with MP alone, patients treated with MP plus Velcade had a 35% reduction in risk of death. The addition of Velcade to MP also delayed cancer progression and improved treatment response rate.
The sustained overall survival benefit provided by Velcade has now been added to the Velcade label. Information has also been added to the label about dosing recommendations for patients with liver impairment.
Reference: Millennium: The Takeda Oncology Company. FDA Approves Addition of Sustained Overall Survival Benefit to Label for Velcade® (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma. Accessed March 4, 2010.
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