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Published on 9 September 2008

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Velcade gains EU approval

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Velcade – a market leader in treating relapsed multiple myeloma – has received European approval in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma, who are not eligible for high-dose chemotherapy with bone marrow transplant.

“Velcade has already made an important contribution for patients with multiple myeloma at first relapse,” said Professor Jesus San Miguel, MD, University of Salamanca in Spain – the principal investigator for the VISTA trial. “The marketing authorisation from the EMEA is encouraging as it suggests that more patients may benefit from earlier treatment.”

A phase III VISTA trial fuelled the EU approval for Velcade as the results recorded, demonstrated statistically superior results across all efficacy endpoints compared to melphalan and prednisone. In particular, complete response (CR) rates were similar to those that have been achieved in the transplant setting.

Velcade monotherapy had already been approved in more than 87 countries for the treatment of relapsed/refractor multiple myeloma in patients who have received at least one prior therapy.



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