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news.Takeda Pharmaceutical and its subsidiary the Takeda Oncology company - Millennium have made decision to withdraw the supplemental new drug application (sNDA) for the use of Velcade (bortezomib) for Injection in combination with rituximab for the treatment of relapsed follicular lymphoma.
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The randomized LYM-3001 trial which enrolled 676 patients with relapsed follicular lymphoma received Velcade and rituximab or rituximab alone.
The primary endpoint of the trial was progression-free survival (PFS) .
The data demonstrated a 1.8-month improvement in median PFS compared with rituximab alone (HR=0.822; P=0.039).
Upon further evaluation based upon discussions with external advisors and the US Food and Drug Administration (FDA), the company has made a business decision to withdraw the application.
In follicular lymphoma, Millennium continues to support evaluation of Velcade in various patient subgroups.
Velcade is approved in the US for use in patients with multiple myeloma and for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.