Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on 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).

This multicenter, international Phase III clinical trial compared VELCADE in combination with melphalan and prednisone (VcMP) versus 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. Due to strong, positive VISTA trial results in June 2008, FDA approved VELCADE in combination for use with previously untreated MM patients.

“This is the largest Phase III registration study to report long-term overall survival in previously untreated multiple myeloma patients,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “This submission of data from the pre-planned long-term survival assessment represents an important milestone in the development of VELCADE.”

VISTA long-term OS data are expected to be presented at a forthcoming scientific conference. VISTA was conducted by Ortho Biotech Oncology Research & Development, a unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (JJPRD) in collaboration with Millennium.

http://www.millennium.com/