VELCADE sNDA receives FDA approval

Jan 5 2010

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

“VELCADE has been shown to provide a significant long-term survival benefit for patients, and we are thrilled to have this prolonged survival data added to the prescribing information.”

The updated survival data, presented at the 51^st Annual Meeting of the American Society of Hematology (ASH), confirmed the OS benefit observed at the original interim analysis that led to the front-line approval of VELCADE in MM in June 2008. This presentation of long-term follow-up data demonstrated that patients treated with VELCADE, melphalan and prednisone (VcMP) continued to have significantly longer OS than those treated with melphalan and prednisone (MP) alone, a commonly used standard of care>

“With multiple myeloma, there is a need for treatments that are clearly and unequivocally demonstrated to help patients live longer,” said Deborah Dunsire, M.D., President and CEO, Millennium. “VELCADE has been shown to provide a significant long-term survival benefit for patients, and we are thrilled to have this prolonged survival data added to the prescribing information.”

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 682-patient clinical trial compared VcMP to MP in patients with previously untreated MM who were not eligible for stem cell transplantation. In the original interim analysis of the VISTA data, the VcMP arm demonstrated a statistically significant improvement above the MP arm in time-to-disease progression (24 months vs. 17 months), complete response (35% vs. 5%), response rate (69% vs. 34%), progression-free survival (18.3 months vs. 14 months), and OS (hazard ratio 0.61) compared to the MP arm. The updated results presented at ASH included the following facts:

• There was a 35 percent reduced risk of death in the VcMP arm, compared with the MP arm (hazard ratio =0.65,>
• The median survival was not reached in the VcMP arm, while the median OS in the MP arm was 43.1 months.
• The safety profile of VELCADE in combination with MP was consistent with the known safety profiles of both VELCADE and MP.