Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma
Friday December 21, 7:00 am ET
CAMBRIDGE, Mass., Dec. 21 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced the submission of a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for VELCADE in the treatment of patients with previously untreated multiple myeloma (MM). The filing is based on data from the 682 patient Phase III VISTA(1) trial, one of the largest, international, randomized clinical trials for patients in this treatment setting. Janssen- Cilag International NV also submitted a Marketing Authorization Application to the European Medicines Evaluations Agency.
The VISTA trial compared VELCADE, melphalan and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. For the VcMP treatment, there was a statistically significant improvement in all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression (TTP) and survival.
"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," said Deborah Dunsire, M.D., President and Chief Executive Officer, Millennium.
(1) VELCADE as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone
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