Millennium files sNDA for Velcade for multiple myeloma

The filing is based on data from the 682 patient Phase III VISTA (Velcade as initial standard therapy in multiple myeloma: assessment with melphalan and prednisone) trial, one of the largest, international, randomized clinical trials for patients in this treatment setting. Janssen-Cilag International also submitted a marketing authorization application to the European Medicines Evaluations Agency.

Deborah Dunsire, president and CEO, Millennium, said: “This submission is an important step in expanding the benefits of Velcade therapy from patients with relapsed disease to those with previously untreated multiple myeloma. We will request a priority review and, if granted, we could expect approval by mid-2008.”