In late December 2007, Millennium successfully submitted a supplemental new drug application (sNDA) to the FDA for Velcade for previously untreated multiple myeloma. The sNDA submitted to the FDA for this indication included data from the Phase III VISTA. study, a large, well-controlled international clinical trial, comparing a Velcade-based regimen to a traditional standard of care. Priority review was granted by the FDA in January 2008. On June 20, 2008, the FDA approved VELCADE in combination for patients with previously untreated multiple myeloma. This means that Millennium can market Velcade to patients who have not had any prior therapies for multiple myeloma (a first-line therapy).