Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) announced that it is withdrawing the supplemental new drug application (sNDA) for the use of Velcade (bortezomib) for injection in combination with rituximab in patients with relapsed follicular lymphoma. The LYM-3001 pivotal clinical trial findings were presented at the American Society of Hematology meeting in 2010 and published in the Lancet Oncology in July 2011.
The addition of Velcade to rituximab demonstrated a 1.8-month improvement in median progression-free survival (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.
The LYM-3001 trial randomized 676 patients with relapsed follicular lymphoma to receive Velcade and rituximab or rituximab alone. The primary endpoint of the trial was progression-free survival. The most common adverse events of grade 3 or higher were neutropenia (11 per cent in the Velcade-rituximab arm and 4 per cent in the rituximab arm), infection (11 per cent and 4 per cent, respectively), diarrhoea (7 per cent and 0 per cent, respectively) and herpes zoster (4 per cent and <1 per cent, respectively), nausea or vomiting (3 per cent and <1 per cent, respectively) and thrombocytopenia (3 per cent and <1 per cent, respectively).
Velcade is approved in the United States 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. Millennium’s clinical development programme for Velcade in non-Hodgkin lymphoma includes ongoing trials in previously untreated mantle cell lymphoma and diffuse large B-cell lymphoma. In follicular lymphoma, Millennium continues to support evaluation of Velcade in various patient subgroups.
Velcade is co-developed by Millennium and Ortho Biotech Oncology Research & Development, unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of Velcade in the US, Janssen-Cilag International N.V. is 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. Velcade is approved in more than 90 countries and has been used to treat more than 300,000 patients worldwide.
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets Velcade, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.