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news.Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for VELCADE (bortezomib) for injection.
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VELCADE is indicated for multiple myeloma (MM) and mantle cell lymphoma.
The submission contains clinical data from the Phase III VISTA trial comparing the use of VELCADE based therapy to a standard of care in patients with previously untreated MM.
The Phase III VISTA trial was conducted by Millennium and its co-development partner Johnson & Johnson Pharmaceutical Research & Development.
The trial randomized 682 patients with newly diagnosed multiple myeloma, ineligible for stem cell transplantation, to receive either VELCADE, melphalan and prednisone (VcMP) or melphalan and prednisone (MP) alone.
The primary endpoint of the trial was time-to-disease progression.
The secondary endpoints comprise overall survival, progression-free survival, response rates, and safety.