FDA Grants Priority Review For VELCADE

Millennium has announced that the FDA has granted priority review to the company’s supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall survival (OS) data from the landmark VISTA trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

The company said that the VISTA trial is the phase III registration study to report long-term overall survival in previously untreated multiple myeloma patients. The multicenter, international phase III clinical trial compared VELCADE in combination with melphalan and prednisone (VcMP) to melphalan and prednisone (MP) alone in patients with previously untreated MM who were not eligible for stem cell transplantation.

In VISTA, the VcMP arm demonstrated a statistically significant improvement in all efficacy endpoints, including time-to-tumor progression, complete response, overall response, progression-free survival, and OS compared to the MP arm.

Nancy Simonian, chief medical officer of Millennium, said: “The data in this filing, derived from long-term follow up of the international VISTA trial, give us additional confidence in the sustained clinical benefit of VELCADE based therapy in previously untreated multiple myeloma patients.”