Millennium Pharmaceuticals achieved positive interim results from an international Phase III VISTA trial in patients with newly diagnosed multiple myeloma that showed Velcade therapy, melphalan and prednisone (VMP), demonstrated a statistically significant improvement in all efficacy measures, including time-to-disease progression, complete remission rate, progression-free survival and overall survival, compared to melphalan and prednisone (MP) alone.
Based on the recommendation of an independent data monitoring committee (IDMC), the control arm of the trial was stopped early to allow patients being treated with MP to have Velcade added to their therapy.
The company plans to file a sNDA in 1Q2008 for the use of Velcade in patients with newly diagnosed multiple myeloma, based on the data from this trial, which was conducted under the SPA process with the FDA.
Velcade is being co-developed by Millennium Pharmaceuticals and JJPRD. Millennium is responsible for commercialization in the U.S., and Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan.
Magazine
