Takeda Receives FDA Approval for Supplemental NDA for Velcade
Millennium: The Takeda Oncology Company and its parent company, Takeda Pharmaceutical Company Limited, report that the US Food and Drug Administration (FDA) has approved Velcade (bortezomib) for the retreatment of adult patients with multiple myeloma who had previously responded to Velcade therapy and relapsed at least six months following completion of prior Velcade treatment. The labeling update includes dosing guidelines as well as safety and efficacy findings for the use of Velcade as a single agent or Velcade in combination with dexamethasone in patients previously treated with Velcade.
Velcade was approved for the treatment of patients with multiple myeloma in 2003. Velcade is also approved for the treatment of patients with mantle cell lymphoma who have already received at least one prior treatment. It was co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies. Millennium is responsible for commercialization of Velcade in the US; Janssen Pharmaceutical Companies are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote Velcade in Japan.