In 2008 Velcade® as New Standard of Care for Initial Therapy in Multiple Myeloma
According to results recently published by Millennium Pharmaceuticals, the addition of Velcade® (bortezomib) to the chemotherapy agent Alkeran® (melphalan) and the steroid prednisone significantly improves survival over Alkeran/prednisone only as initial therapy for multiple myeloma.
Multiple myeloma is diagnosed in approximately 20,000 people annually in the United States. It is the second most common hematologic malignancy (cancer originating in blood cells). Multiple myeloma is a cancer of the blood that affects the plasma cells. Plasma cells are an important part of the immune system; they produce antibodies to help fight infection and disease. Multiple myeloma is characterized by an excess production of abnormal plasma cells. Symptoms include increased risk of bacterial infections and impaired immune responses. Because patients whose cancer has returned following prior therapy are typically considered incurable, the goal of treatment is to extend survival and maintain quality of life.
Velcade is considered a proteosome inhibitor. Proteosomes are proteins found in virtually all cells. They are responsible for the breakdown and reuse of a cell’s other proteins. Proteosomes regulate several aspects of cellular activity, including survival. By inhibiting proteosomes Velcade has demonstrated an ability to reduce cellular survival.
Researchers conducted a large, international, Phase III clinical trial (trial prior to FDA review), referred to as the VISTA trial, that compared Velcade/Alkeran/prednisone to Alkeran/prednisone only as initial treatment among patients with multiple myeloma.
- Overall survival, time to cancer progression, complete disappearances of detectable cancer, and progression-free survival were all significantly improved with the addition of Velcade to Alkeran/prednisone.
- Because these results clearly indicate that the addition of Velcade provides better results, the trial was stopped early based on the recommendation of an independent data monitoring committee (IDMC) so that patients being treated with Alkeran/prednisone could be treated with the addition of Velcade.
The researchers concluded: “These results position Velcade-based therapy as a new standard of care for newly diagnosed multiple myeloma patients.” A supplemental new drug application (sNDA) is planned for filing with the FDA for approval of Velcade as initial therapy for multiple myeloma.
Reference: Millennium Pharmaceuticals, Inc. Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of Velcade® (bortezomib) for Injection Based Therapy Across All Endpoints. Available at: =. Accessed September 2007.
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