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 51st 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.”