Millennium submits VELCADE sNDA to FDA to add OS data for previously untreated multiple myeloma

Jul 20 2011

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for VELCADE^® (bortezomib) for injection to add overall survival (OS) data after a five-year follow up to the product label. The submission contains clinical data from the landmark Phase III VISTA trial comparing the use of VELCADE based therapy to an established standard of care in patients with previously untreated multiple myeloma (MM). VELCADE is currently the only therapy FDA-approved for MM with an overall survival advantage in its label.

The international Phase III VISTA trial was conducted by Millennium and its co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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, with secondary endpoints including overall survival, progression-free survival, response rates, and safety.