September 03, 2009
FDA accepts sNDA for Velcade for previously untreated multiple myelomaMillennium Pharmaceuticals announced that the FDA has accepted for review a supplemental New Drug Application (sNDA) for Velcade (bortezomib injection) based on long-term overall survival data from the VISTA trial examining the use of Velcade-based therapy in patients with previously untreated multiple myeloma. VISTA (Velcade as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone), was a Phase 3, multicenter, international clinical trial enrolling 682 patients with newly diagnosed multiple myeloma who were not eligible for stem cell transplantation. Patients were randomized to receive either Velcade, melphalan and prednisone (VcMP) or melphalan and prednisone (MP) alone. The primary endpoint of the trial was time-to-disease progression, with secondary endpoints including overall survival, progression-free survival, complete remission rate, and safety.
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