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Published on 31 January 2008

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Priority FDA review for bortezomib

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The FDA has granted priority review to a supplemental New Drug Application for bortezomib (Velcade®) as a treatment for patients with newly diagnosed multiple myeloma.

The submission is based in part on data from the phase III VISTA(1) study, which compared a combination of bortezomib, melphalan and prednisone (VcMP) with the standard regimen of melphalan and prednisone (MP) in 682 patients with newly diagnosed disease, unsuitable for stem cell transplantation.

In the UK, bortezomib is licensed for use in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.

FDA



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