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VELCADE® Adds Long-Term Overall Survival Benefit to Label
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.

The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment.

The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM). The updated survival data, presented at the 51st Annual Meeting of the American Society of Hematology (ASH), confirmed the OS benefit observed at the original interim analysis that led to the front-line approval of VELCADE in MM in June 2008.

For more information, click here to view the press release.
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