Millennium Gets Priority Review for Velcade

Millennium’s Velcade was granted priority review from the FDA for patients with newly diagnosed multiple myeloma (MM). The sNDA for this indication included data from the Phase III VISTA study, a large, international trial, comparing a Velcade based regimen to a traditional standard of care.

Priority review is granted for a treatment that addresses an unmet medical need and demonstrates an improvement over existing therapies. The FDA expedites the approval process for these applications from ten to six months.

The VISTA trial included 682 patients with newly diagnosed MM ineligible for stem cell transplantation. The trial compared Velcade, melphalan and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. VcMP achieved a statistically significant improvement across all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression (TTP) and survival (progression-free survival and overall survival). VcMP demonstrated an immunofixation-negative CR rate of 35% compared to 5% in the MP arm.