Millennium: The Takeda Oncology Company Submits Supplemental New Drug Application with FDA for Long-Term Overall Survival Results of VELCADE in Previously Untreated Multiple Myeloma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.
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