March 8, 2009

Velcade® Approved for Initial Therapy of Multiple Myeloma


Velcade® Approved for Initial Therapy of Multiple Myeloma

The United States Food and Drug Administration (FDA) has approved Velcade® (bortezomib) as initial therapy for the treatment of multiple myeloma. Velcade is already approved for the treatment of patients with multiple myeloma who have received prior therapies, as well as for patients with mantle cell lymphoma who have received prior therapies. These results were recently published in a press release by Millennium Pharmaceuticals.

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.

The new FDA approval for Velcade was based on results from a clinical trial called the VISTA trial. The VISTA trial 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; patients being treated with Alkeran/prednisone could thus be treated with the addition of Velcade.

Patients with newly diagnosed multiple myeloma may wish to speak with their physician regarding their individual risks and benefits of treatment with Velcade.

Reference: Millennium Pharmaceuticals. FDA approves Velcade® (bortezomib) for injection for patients with previously untreated multiple myeloma. Available at: Accessed June 2008.

Related News: Velcade® as New Standard of Care for Initial Therapy in Multiple Myeloma (09/18/2007)

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