Millennium's sNDA for VELCADE granted priority review by the FDA

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (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 VISTA trial is the largest Phase III registration study to report long-term overall survival in previously untreated multiple myeloma patients. This 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.

“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,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium.

Priority review is granted by the FDA for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA expedites the approval process from ten to six months for applications granted priority review.

Updated VISTA long-term OS data are expected to be presented at a forthcoming scientific conference. VISTA was conducted by Janssen-Cilag in collaboration with Millennium.