FDA Approves Addition of Sustained Overall Survival Benefit to Label for VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 VISTA1 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).