LYCOS RETRIEVER
The Millennium: Chief Medical Officer
built 216 days ago
"Results from this trial build on the growing body of data showing that VELCADE based regimens deliver high CR rates that translate to increased post- transplantation benefits," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "Since we know high CR rates lead to longer-term survival, we believe these data position VELCADE based therapy as a new standard of care for front-line patients."
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"We designed this trial to combine three active agents in NHL with the goal of enhancing the clinical outcomes of this patient population," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are hopeful this novel combination will add to the growing body of data that show the potential of VELCADE to be part of the standard of care in follicular lymphoma, similar to what we've seen in multiple myeloma."
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"An approval in front-line multiple myeloma would double the number of patients eligible to receive the benefit of VELCADE," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are confident that VELCADE based therapies will become standard of care, since physicians typically use the most active agents in the front-line setting to improve long-term outcomes for patients."
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"Priority review designation puts us on track for a potential label expansion decision by June 20," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The rapid action by the FDA puts us one step closer to establishing VELCADE based therapies as a standard of care for patients with newly diagnosed multiple myeloma."
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"This VELCADE based therapy offers patients durable and complete remissions, formerly only accessible to transplant patients," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are filing a sNDA this month to seek approval in this important treatment setting, which could significantly increase the number of patients eligible to benefit from VELCADE."
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