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With suvivival data from VISTA trial, FDA makes VELCADE first front-line multiple myeloma therapy to include overall survival benefit after three-year follow-up in label. |
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With these new approvals, patients with multiple myeloma may now receive VELCADE earlier following an initial disease diagnosis. |
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Dr. Durie says that the statistics from the VISTA trial leave no doubt that combination therapy with bortezomib is superior to MP alone. However, he raises the issue, "how does this clear-cut evidence inform treatment decisions?" |
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New Indication Provides Treatment-Free Interval As an Option |
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The FDA granted approval for VELCADE use, without dose adjustments, in patients with impaired kidney function, including those requiring dialysis. Impaired kidney function is a common complication related to myeloma, affecting approximately 30% of patients at diagnosis and a much larger percentage throughout the course of the disease. |
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The combination therapy of VELCADE, melphalan and prednisone (VMP) demonstrates a significant advantage for patients newly diagnosed with myeloma. The therapy is already approved for use in patients who have received a previous treatment. |
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Interim analysis results of the large, international Phase III VISTA(1) trial in patients with newly diagnosed multiple myeloma showed that the therapy of VELCADE, melphalan and prednisone (VMP) demonstrated a highly statistically significant improvement in all efficacy measures. |
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Data Presented at the ASCO Cancer Conference |
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Combination Provides 43% Improvement in Time to Disease Progression |
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According to results recently presented at the 2005 ASCO meeting, treatment with Velcade (bortezomib) may overcome the poor prognosis associated with del(13), considered a poor prognostic indicator for survival in multiple myeloma. |
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The European Commission has approved the use of VELCADE® (bortezomib) for Injection as a second-line treatment in patients with multiple myeloma. |
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This approval expands the label to include the treatment of multiple myeloma patients who have received at least one prior therapy. The approval was based on data from the randomized Phase III APEX study that compared single-agent VELCADE to high-dose dexamethasone. The study demonstrated a statistically significant survival advantage in the VELCADE arm of the study. |
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